Arrow
MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Device, Integral Hemostasis Valve, Sharps Safety Features, and Maximal Barrier Precautions for use with
13manufacturers in China registered for this device type
1,036catalogue numbers in this listing
4510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (5), Beijing (3), Shanghai (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Mehow Innovative (Huizhou) Ltd. | Huizhou | Guangdong | Contract manufacturer | 11 |
| Tianjin Demax Medical Technology Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 5 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Shanghai INT Medical Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Lepu Medical Technology (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
| Beijing Target Medical Technologies Inc. | Beijing | Beijing | Contract manufacturer | 7 |
| Beijing Demax Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 5 |
| Curatia Medical Limited | Suzhou | Jiangsu | Specification developer | 5 |
| Tianjin Ethylene Oxide Sterilization Technology Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 4 |
| Shanghai Microport EP Medtech Co., Ltd. | Shanghai | Shanghai | Manufacturer | 3 |
| Becton Dickinson Medical Devices Co., Ltd. Suzhou | Suzhou | Jiangsu | Contract manufacturer | 2 |
| Cardiocycle Medical(Suzhou) Co., Ltd. | Suzhou | Jiangsu | Complaint-file establishment | 1 |
Showing 12 of 13. All 13 manufacturers in China registered for Introducer, Catheter
Record
| Listed by | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | DYB |
| Device type | Introducer, Catheter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1340 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K011761 |
| Record published | 2023-07-07 |
| Record revised | 2025-09-24 (version 27) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 20 to 25 °C |
| Packaging | Case of 5, case of 10, box of 5, case, box of 10, case of 3 |
| Sizes | Catheter gauge 4 to 9 Fr; width 5 to 24 cm; length 7 to 24 cm |
| Distribution end date | 2025-09-24 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN919997 | In distribution | |
| IPN036463 | In distribution | |
| IPN920032 | In distribution | |
| IPN038393 | In distribution | |
| IPN920377 | In distribution | |
| IPN037068 | In distribution | |
| IPN917259 | In distribution | |
| IPN055751 | In distribution | |
| IPN034706 | In distribution | |
| IPN923925 | In distribution | |
| IPN036937 | In distribution | |
| IPN035964 | In distribution | |
| IPN920819 | In distribution | |
| IPN036537 | In distribution | |
| IPN036997 | In distribution | |
| IPN925110 | In distribution | |
| IPN921163 | In distribution | |
| IPN926155 | In distribution | |
| IPN033885 | In distribution | |
| IPN001146 | Length 24 cm | In distribution |
| IPN035882 | In distribution | |
| IPN037020 | In distribution | |
| IPN925071 | In distribution | |
| IPN925290 | In distribution | |
| IPN036843 | In distribution | |
| IPN036682 | In distribution | |
| IPN034694 | In distribution | |
| IPN925142 | In distribution | |
| IPN037167 | In distribution | |
| IPN038100 | In distribution | |
| IPN036494 | In distribution | |
| IPN032789 | In distribution | |
| IPN037296 | In distribution | |
| IPN034494 | In distribution | |
| IPN034517 | In distribution | |
| IPN000013 | Width 11 cm | In distribution |
| IPN036444 | In distribution | |
| IPN033617 | In distribution | |
| IPN038525 | In distribution | |
| IPN036059 | In distribution | |
| IPN000116 | In distribution | |
| IPN923370 | In distribution | |
| IPN037222 | In distribution | |
| IPN929716 | In distribution | |
| IPN038495 | In distribution | |
| IPN928661 | In distribution | |
| IPN032804 | In distribution | |
| IPN033184 | In distribution | |
| IPN032637 | In distribution | |
| IPN032980 | In distribution | |
| IPN036915 | In distribution | |
| IPN921174 | In distribution | |
| IPN000143 | In distribution | |
| IPN033597 | In distribution | |
| IPN037411 | In distribution | |
| IPN034488 | In distribution | |
| IPN033958 | In distribution | |
| IPN034727 | In distribution | |
| IPN925115 | In distribution | |
| IPN920379 | In distribution | |
| IPN033612 | In distribution | |
| IPN038521 | In distribution | |
| IPN000124 | In distribution | |
| IPN920044 | In distribution | |
| IPN037259 | In distribution | |
| IPN000156 | In distribution | |
| IPN925102 | In distribution | |
| IPN010813 | In distribution | |
| IPN055806 | In distribution | |
| IPN036677 | In distribution | |
| IPN037366 | In distribution | |
| IPN032745 | In distribution | |
| IPN920529 | In distribution | |
| IPN920050 | In distribution | |
| IPN034700 | In distribution | |
| IPN032904 | In distribution | |
| IPN035476 | In distribution | |
| IPN036373 | In distribution | |
| IPN920659 | In distribution | |
| IPN921150 | In distribution | |
| IPN037064 | In distribution | |
| IPN030358 | In distribution | |
| IPN920382 | In distribution | |
| IPN034832 | In distribution | |
| IPN037200 | In distribution | |
| IPN919667 | In distribution | |
| IPN921157 | In distribution | |
| IPN920035 | In distribution | |
| IPN920372 | In distribution | |
| IPN920049 | In distribution | |
| IPN034839 | In distribution | |
| IPN037064 | In distribution | |
| IPN925061 | In distribution | |
| IPN032977 | In distribution | |
| IPN000020 | Catheter Gauge 4 Fr | In distribution |
| IPN001136 | Catheter Gauge 6 Fr | In distribution |
| IPN036979 | In distribution | |
| IPN930196 | In distribution | |
| IPN923735 | In distribution | |
| IPN036362 | In distribution | |
| IPNB00062 | In distribution | |
| IPN921089 | In distribution | |
| IPN037570 | In distribution | |
| IPN055077 | In distribution | |
| IPN037267 | In distribution | |
| IPN035877 | In distribution | |
| IPN037339 | In distribution | |
| IPN921153 | In distribution | |
| IPN036898 | In distribution | |
| IPN919682 | In distribution | |
| IPN038039 | In distribution | |
| IPN033132 | In distribution | |
| IPN923372 | In distribution | |
| IPN033901 | In distribution | |
| IPN055748 | In distribution | |
| IPN035875 | In distribution | |
| IPN001128 | Length 24 cm | In distribution |
| IPN033899 | In distribution | |
| IPN000169 | In distribution | |
| IPN036578 | In distribution | |
| IPN036354 | In distribution | |
| IPN036638 | In distribution | |
| IPN921143 | In distribution | |
| IPN929679 | In distribution | |
| IPN036450 | In distribution | |
| IPN036496 | In distribution | |
| IPN034477 | In distribution | |
| IPN034458 | In distribution | |
| IPN033893 | In distribution | |
| IPN032638 | In distribution | |
| IPN036928 | In distribution | |
| IPN036388 | In distribution | |
| IPN919649 | In distribution | |
| IPN035930 | In distribution | |
| IPN029726 | In distribution | |
| IPN924047 | In distribution | |
| IPN034697 | In distribution | |
| IPN925144 | In distribution | |
| IPN923927 | In distribution | |
| IPN920376 | In distribution | |
| IPN038111 | In distribution | |
| IPN036650 | In distribution | |
| IPN929719 | In distribution | |
| IPN000022 | Catheter Gauge 5 Fr | In distribution |
| IPN035858 | In distribution | |
| IPN036550 | In distribution | |
| IPN034536 | In distribution | |
| IPN000006 | Catheter Gauge 5 Fr | In distribution |
| IPN911820 | In distribution | |
| IPN033580 | In distribution | |
| IPN032640 | In distribution | |
| IPN039122 | In distribution | |
| IPN055900 | In distribution | |
| IPN001126 | Catheter Gauge 5 Fr | In distribution |
| IPN919723 | In distribution | |
| IPN925160 | In distribution | |
| IPN030355 | Catheter Gauge 9 Fr | In distribution |
| IPN032790 | In distribution | |
| IPN000132 | In distribution | |
| IPN929718 | In distribution | |
| IPN920350 | In distribution | |
| IPN032734 | In distribution | |
| IPN920455 | In distribution | |
| IPN034815 | In distribution | |
| IPN036650 | In distribution | |
| IPN928002 | In distribution | |
| IPN929490 | In distribution | |
| IPN034514 | In distribution | |
| IPN915243 | In distribution | |
| IPN037692 | In distribution | |
| IPN036799 | In distribution | |
| IPN037036 | In distribution | |
| IPN929714 | In distribution | |
| IPN034713 | In distribution | |
| IPN925073 | In distribution | |
| IPN000123 | In distribution | |
| IPN036927 | In distribution | |
| IPN917279 | In distribution | |
| IPN055575 | In distribution | |
| IPN000007 | Width 11 cm | In distribution |
| IPN925081 | In distribution | |
| IPN037221 | In distribution | |
| IPN036824 | In distribution | |
| IPN032907 | In distribution | |
| IPN925137 | In distribution | |
| IPN000198 | Catheter Gauge 7 Fr | In distribution |
| IPN036522 | In distribution | |
| IPN034219 | In distribution | |
| IPN034451 | In distribution | |
| IPN033581 | In distribution | |
| IPN923929 | In distribution | |
| IPN919680 | In distribution | |
| IPN037085 | In distribution | |
| IPN037723 | In distribution | |
| IPN036933 | In distribution | |
| IPN033900 | In distribution | |
| IPN037298 | In distribution | |
| IPN032884 | In distribution | |
| IPNB00183 | In distribution | |
| IPN035878 | In distribution | |
| IPN919666 | In distribution | |
| IPN929370 | In distribution | |
| IPNB00184 | In distribution | |
| IPN920421 | In distribution | |
| IPN920586 | In distribution | |
| IPN033901 | In distribution | |
| IPN920469 | In distribution | |
| IPN035476 | In distribution | |
| IPN034837 | In distribution | |
| IPN010815 | In distribution | |
| IPN038617 | In distribution | |
| IPN038616 | In distribution | |
| IPN033183 | In distribution | |
| IPN000185 | Catheter Gauge 6 Fr | In distribution |
| IPN036449 | In distribution | |
| IPN036471 | In distribution | |
| IPN922633 | In distribution | |
| IPN030351 | In distribution | |
| IPN036329 | In distribution | |
| IPN929374 | In distribution | |
| IPN920046 | In distribution | |
| IPN034809 | In distribution | |
| IPN000171 | Catheter Gauge 9 Fr | In distribution |
| IPN000018 | Width 24 cm | In distribution |
| IPN034823 | In distribution | |
| IPN034510 | In distribution | |
| IPN925114 | In distribution | |
| IPN032729 | In distribution | |
| IPN000194 | Catheter Gauge 4 Fr | In distribution |
| IPN033134 | In distribution | |
| IPN037499 | In distribution | |
| IPN036638 | In distribution | |
| IPN921151 | In distribution | |
| IPN920646 | In distribution | |
| IPN037216 | In distribution | |
| IPN036861 | In distribution | |
| IPN000147 | In distribution | |
| IPN033904 | In distribution | |
| IPN033888 | In distribution | |
| IPN032730 | In distribution | |
| IPN034841 | In distribution | |
| IPN034725 | In distribution | |
| IPN038494 | In distribution | |
| IPN037415 | In distribution | |
| IPN030350 | In distribution | |
| IPN920052 | In distribution | |
| IPN929491 | In distribution | |
| IPN915315 | Length 10 cm | In distribution |
| IPN030344 | In distribution | |
| IPN033006 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Demax | Beijing Demax Medical Technology Co., Ltd. | 2,841 |
| Prelude IDeal™ | Merit Medical Systems, Inc. | 294 |
| Fast-Cath™ | St. Jude Medical | 213 |
| Flexor | Cook Incorporated | 182 |
| Prelude Ease™ | Merit Medical Systems, Inc. | 176 |
| Performer | Cook Incorporated | 174 |
| VSI | Teleflex Medical LLC | 154 |
| Peel-Away | Cook Incorporated | 153 |
| OptiSeal™ | Greatbatch Medical | 127 |
| Brilliant | Lepu Medical Technology (Beijing) Co., Ltd. | 122 |
| Super Sheath | Togo Medikit Co., Ltd. | 122 |
| Tearaway Introducer Set | Galt Medical Corp. | 96 |
Showing 12 of 439. All products under Introducer, Catheter
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K123974 | 2013-02-21 |
| K060519 | 2006-05-05 |
| K861951 | 1986-06-19 |
| K860307 | 1986-05-20 |
Recalls Naming This Product
33 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2026-04-21 | Class I | Nonconforming Material/Component | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-bas | 426,041 | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | UDI-DI | 2026-03-11 | Class II | Process control | Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured | 95 | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2019-12-20 | Class II | Incorrect or no expiration date | Product lidstock contains the incorrect expiration date for the product | 410 | 2021-02-25 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2019-08-06 | Class II | Packaging process control | Products may contain the incorrect banner card within the kit | 520 eaches | 2020-09-29 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2018-05-23 | Class II | Process control | Product contains dry natural rubber latex. Label states Latex Free. | 60 units | 2020-05-20 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2018-04-11 | Class II | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. | 416,055 total products | 2020-05-15 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2018-04-11 | Class II | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. | 416,055 total products | 2020-05-15 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2018-04-11 | Class II | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. | 416,055 total products | 2020-05-15 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2018-04-11 | Class II | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. | 416,055 total products | 2020-05-15 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2018-04-11 | Class II | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. | 416,055 total products | 2020-05-15 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2018-04-11 | Class II | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. | 416,055 total products | 2020-05-15 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2018-04-11 | Class II | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. | 416,055 total products | 2020-05-15 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2018-04-11 | Class II | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. | 416,055 total products | 2020-05-15 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2018-04-11 | Class II | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. | 416,055 total products | 2020-05-15 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2018-04-11 | Class II | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. | 416,055 total products | 2020-05-15 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2017-12-22 | Class II | Process control | Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed. | 2020-05-27 | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2017-12-22 | Class II | Process control | Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed. | 2020-05-27 | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2017-11-14 | Class II | Labeling mix-ups | Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practices during central line insertions. | 18,124 total | 2019-07-15 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2017-11-14 | Class II | Labeling mix-ups | Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practices during central line insertions. | 18,124 total | 2019-07-15 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2017-10-26 | Class II | Nonconforming Material/Component | The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life. | 1190 | 2019-12-10 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2017-06-12 | Class II | Device Design | Arrow is recalling additional lots that were identified as part of an active recall. Arrow is recalling the affected product due to the possibility that the catheter peel-away component hub tabs may prematurely detach when the practitioner | 9,037 units in the U.S. and 4,505 Internationally | 2018-09-06 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2017-05-09 | Class II | Packaging | Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility. | 27,485 units distributed in U.S, 4,371 units distributed int | 2018-09-17 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2016-01-12 | Class II | Packaging process control | Arrow has issued a recall for these products due to potential packaging damage. The sterility of the products cannot be guaranteed. If non-sterile product is used there is a potential for infection to occur. | 56,521 units | 2018-02-26 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2014-04-14 | Class II | Process control | Arrow is recalling the Arrow Percutaneous Sheath Introducer Kits due to dilator tip damage noted during internal inspection. Dilator tip damage has the potential to result in vessel damage. | 15424 | 2016-10-14 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2013-10-09 | Class II | Process control | There is a risk that the introducer needles packaged within the kits can be partially or fully occluded, which can cause delayed treatment or an adverse event when used on a patient. | 294430 | 2015-08-12 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2011-03-25 | Not classified | Other | Labeling discrepancy – the outer corrugate label as well as a card inside the package state the product contains dry natural rubber – this is not duplicated on the unit packaging. | 840 | 2014-01-29 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2010-12-20 | Not classified | Other | Packaging may have been compromised, and sterility of product cannot be guaranteed. | 320 units | 2014-09-25 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2010-07-29 | Not classified | Mixed-up of materials/components | Incorrectly assembled 18 Ga x 2 1/2 Introducer Needle | 16 | 2012-07-05 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2009-11-24 | Not classified | Nonconforming Material/Component | Q-Syte Component contained in kits was recalled by manufacturer due to the potential for embolism if used with a central venous catheter. | 117 kits | 2012-01-18 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2009-11-24 | Not classified | Nonconforming Material/Component | Q-Syte Component contained in kits was recalled by manufacturer due to the potential for embolism if used with a central venous catheter. | 65 kits | 2012-01-18 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2009-02-11 | Not classified | Device Design | Leakage: Material not lipid resistant, may crack and/or leak. Use of this device with lipid containing solutions or 70% isopropyl alcohol may cause leakage or air embolism. | 900,000 total, all products | 2010-07-22 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2009-02-11 | Not classified | Device Design | Leakage: Material not lipid resistant, may crack and/or leak. Use of this device with lipid containing solutions or 70% isopropyl alcohol may cause leakage or air embolism. | 900,000 total, all products | 2010-07-22 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2009-02-11 | Not classified | Device Design | Leakage: Material not lipid resistant, may crack and/or leak. Use of this device with lipid containing solutions or 70% isopropyl alcohol may cause leakage or air embolism. | 900,000 total, all products | 2010-07-22 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.