Arrow
Equipo de Cateterizacian Venosa Central de Dos Lumen con Catater con Punta Flexible Blue FlexTip. Two-Lumen Central Venous Catheterization Set with Blue FlexTip(R) Catheter
14manufacturers in China registered for this device type
1,249catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (5), Jiangsu (5), Guangdong (3). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
| Covidien Medical Products (Shanghai) Manufacturing LLC | Shanghai | Shanghai | Contract manufacturer | 8 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Goals Sterilization Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 26 |
| Wuxi Goals Medical Technology Co., Ltd. | Yixing | Jiangsu | Contract manufacturer | 24 |
| Suzhou Zenith Vascular Scitech Limited | Suzhou | Jiangsu | Manufacturer | 6 |
| Haolang Technology (Foshan) Limited Corporation | Foshan | Guangdong | Contract manufacturer | 6 |
| OrbusNeich Medical (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Complaint-file establishment | 5 |
| Curatia Medical Limited | Suzhou | Jiangsu | Specification developer | 5 |
| Shanghai Wallaby Medical Technologies Co., Inc. | Shanghai | Shanghai | Contract manufacturer | 5 |
| DK Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
Showing 12 of 14. All 14 manufacturers in China registered for Catheter, Percutaneous
Record
| Listed by | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | DQY |
| Device type | Catheter, Percutaneous |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K862056 |
| Record published | 2016-10-20 |
| Record revised | 2023-09-22 (version 27) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| 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, peel pack of 5, case of 20, box of 25, case |
| Sizes | Catheter gauge 4 to 14 Fr; length 5 to 20 cm; catheter length 20 cm |
| Distribution end date | 2026-07-29 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN036019 | In distribution | |
| IPN914754 | In distribution | |
| IPN033017 | In distribution | |
| IPN917021 | In distribution | |
| IPN033019 | In distribution | |
| IPN039996 | In distribution | |
| IPN034549 | In distribution | |
| IPN918711 | In distribution | |
| IPN039901 | In distribution | |
| IPN039947 | In distribution | |
| IPN039904 | In distribution | |
| IPN054679 | In distribution | |
| IPN033200 | Catheter Gauge 7 Fr | In distribution |
| IPN030104 | In distribution | |
| IPN033089 | In distribution | |
| IPN030085 | In distribution | |
| IPN036036 | In distribution | |
| IPN921069 | In distribution | |
| IPN031497 | In distribution | |
| IPN030792 | In distribution | |
| SAC-01618-B | In distribution | |
| IPN033913 | In distribution | |
| IPN032702 | In distribution | |
| IPN030859 | In distribution | |
| IPN917011 | In distribution | |
| IPN039891 | In distribution | |
| IPN032681 | In distribution | |
| IPN030002 | In distribution | |
| IPN911809 | In distribution | |
| IPN034556 | In distribution | |
| IPN030086 | In distribution | |
| IPN033857 | In distribution | |
| IPN030749 | In distribution | |
| IPN055180 | In distribution | |
| IPN919237 | In distribution | |
| IPN036038 | In distribution | |
| IPN030098 | Length 20 cm | In distribution |
| IPN914741 | In distribution | |
| IPN036040 | In distribution | |
| IPN036996 | In distribution | |
| IPN918749 | In distribution | |
| IPN055219 | In distribution | |
| IPN037190 | In distribution | |
| IPN030079 | In distribution | |
| IPN033180 | In distribution | |
| IPN033214 | In distribution | |
| IPN030853 | In distribution | |
| IPN030781 | In distribution | |
| IPN030794 | In distribution | |
| IPN039954 | In distribution | |
| IPN921209 | In distribution | |
| IPN037008 | In distribution | |
| IPN033924 | In distribution | |
| IPN039868 | In distribution | |
| IPN034200 | In distribution | |
| IPN033932 | In distribution | |
| IPN035467 | In distribution | |
| IPN035708 | In distribution | |
| IPN919244 | In distribution | |
| IPN920697 | In distribution | |
| IPN034553 | In distribution | |
| IPN034220 | In distribution | |
| IPN924905 | In distribution | |
| IPN054739 | In distribution | |
| IPN033090 | In distribution | |
| IPN030463 | In distribution | |
| IPN920705 | In distribution | |
| IPN036890 | In distribution | |
| IPN054694 | In distribution | |
| IPN055196 | In distribution | |
| IPN029684 | In distribution | |
| IPN918482 | In distribution | |
| IPN037540 | In distribution | |
| IPN920822 | In distribution | |
| IPN029772 | In distribution | |
| IPN030623 | In distribution | |
| IPN033915 | In distribution | |
| IPN037026 | In distribution | |
| IPN928981 | In distribution | |
| IPN030790 | In distribution | |
| IPN033013 | In distribution | |
| IPN033084 | In distribution | |
| IPN033089 | In distribution | |
| IPN039906 | In distribution | |
| IPN036095 | In distribution | |
| IPN028405 | In distribution | |
| IPN033063 | In distribution | |
| IPN039906 | In distribution | |
| IPN038637 | In distribution | |
| IPN919505 | In distribution | |
| IPN038314 | In distribution | |
| IPN034679 | In distribution | |
| IPN034402 | In distribution | |
| IPN929366 | In distribution | |
| IPN039942 | In distribution | |
| IPN921189 | In distribution | |
| IPN914747 | In distribution | |
| IPN030777 | In distribution | |
| IPN055005 | In distribution | |
| IPN037123 | Catheter Gauge 7 Fr | In distribution |
| IPN030794 | In distribution | |
| IPN916826 | In distribution | |
| IPN030365 | In distribution | |
| IPN033622 | In distribution | |
| IPN033191 | Catheter Gauge 7 Fr | In distribution |
| IPN030251 | In distribution | |
| IPN030318 | In distribution | |
| IPN030248 | In distribution | |
| IPN035706 | In distribution | |
| IPN032684 | In distribution | |
| IPN054779 | In distribution | |
| IPN033212 | In distribution | |
| IPN054700 | In distribution | |
| IPN920701 | In distribution | |
| IPN035472 | In distribution | |
| IPN000129 | In distribution | |
| IPN000176 | In distribution | |
| IPN035468 | In distribution | |
| IPN921196 | In distribution | |
| IPN914753 | In distribution | |
| IPN918705 | In distribution | |
| IPN030893 | In distribution | |
| IPN038306 | In distribution | |
| IPN037202 | In distribution | |
| IPN033919 | In distribution | |
| IPN033094 | In distribution | |
| IPN917009 | In distribution | |
| IPN055155 | In distribution | |
| IPN055166 | In distribution | |
| IPN033920 | In distribution | |
| IPN030009 | In distribution | |
| IPN030597 | In distribution | |
| IPN038303 | In distribution | |
| IPN039886 | In distribution | |
| IPN036587 | In distribution | |
| IPN030899 | In distribution | |
| IPNB00213 | In distribution | |
| IPN036582 | In distribution | |
| IPN033188 | Catheter Gauge 7 Fr | In distribution |
| IPN036632 | In distribution | |
| IPN920507 | In distribution | |
| IPN032661 | In distribution | |
| IPN033063 | In distribution | |
| IPN037542 | In distribution | |
| IPN036089 | In distribution | |
| IPN030854 | In distribution | |
| IPN030759 | In distribution | |
| IPN918766 | In distribution | |
| IPN036887 | In distribution | |
| IPN033933 | In distribution | |
| IPN030781 | In distribution | |
| IPN030778 | In distribution | |
| IPN928944 | In distribution | |
| IPN032625 | In distribution | |
| IPN037109 | In distribution | |
| IPN030336 | In distribution | |
| IPN001312 | In distribution | |
| IPN918780 | In distribution | |
| IPN030084 | In distribution | |
| IPN030865 | In distribution | |
| IPN033020 | In distribution | |
| IPN030332 | In distribution | |
| IPN037571 | In distribution | |
| IPN918708 | In distribution | |
| IPN037565 | In distribution | |
| IPN919240 | In distribution | |
| IPN918695 | In distribution | |
| IPN037757 | In distribution | |
| IPN030791 | In distribution | |
| IPN037223 | In distribution | |
| IPN038428 | Length 8 cm | In distribution |
| IPN918641 | In distribution | |
| IPN918782 | In distribution | |
| IPN033181 | In distribution | |
| IPN915671 | Catheter Gauge 8 Fr | In distribution |
| IPN030744 | In distribution | |
| IPN054747 | In distribution | |
| IPN030733 | In distribution | |
| IPN918752 | In distribution | |
| IPN920503 | In distribution | |
| IPN037092 | In distribution | |
| IPN036039 | In distribution | |
| IPN055153 | In distribution | |
| IPN036089 | In distribution | |
| IPN037114 | In distribution | |
| IPN034167 | In distribution | |
| IPN033098 | In distribution | |
| IPN030771 | In distribution | |
| IPN037209 | In distribution | |
| IPN000174 | In distribution | |
| IPN035475 | In distribution | |
| IPN039991 | In distribution | |
| IPN032662 | In distribution | |
| IPN038636 | In distribution | |
| IPN000152 | In distribution | |
| IPN054897 | In distribution | |
| IPN920678 | In distribution | |
| IPN039921 | In distribution | |
| IPN054589 | In distribution | |
| IPN055161 | In distribution | |
| IPN922664 | In distribution | |
| IPN039894 | In distribution | |
| IPN917012 | In distribution | |
| IPN921191 | In distribution | |
| IPN921208 | In distribution | |
| IPN030907 | In distribution | |
| IPN030886 | In distribution | |
| IPN030769 | In distribution | |
| IPN030863 | In distribution | |
| IPN039889 | In distribution | |
| IPN039858 | In distribution | |
| IPN918519 | In distribution | |
| IPN036582 | In distribution | |
| IPN055199 | In distribution | |
| IPN030908 | In distribution | |
| IPN033094 | Catheter Gauge 5.5 Fr | In distribution |
| IPN035965 | In distribution | |
| IPN055246 | In distribution | |
| IPN916883 | In distribution | |
| IPN030078 | In distribution | |
| IPN055165 | In distribution | |
| IPN031509 | In distribution | |
| IPN914748 | In distribution | |
| IPN030763 | In distribution | |
| IPN036098 | In distribution | |
| IPN929706 | In distribution | |
| IPN919463 | In distribution | |
| IPN920111 | In distribution | |
| IPN032617 | In distribution | |
| IPN000130 | In distribution | |
| IPN033916 | In distribution | |
| SAC-01620-B | In distribution | |
| IPN038530 | In distribution | |
| IPN030721 | In distribution | |
| IPN033127 | In distribution | |
| IPN033130 | In distribution | |
| IPN030789 | In distribution | |
| IPN030248 | Catheter Gauge 7 Fr | In distribution |
| IPN034586 | In distribution | |
| IPN000137 | In distribution | |
| IPN037156 | In distribution | |
| IPN054701 | In distribution | |
| IPN034589 | In distribution | |
| IPN919740 | In distribution | |
| IPN000142 | In distribution | |
| IPN030879 | In distribution | |
| IPN036266 | In distribution | |
| IPN054752 | In distribution | |
| IPN054900 | In distribution | |
| IPN038516 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Launcher™ | Medtronic, Inc. | 3,805 |
| Sherpa NX Balanced™ | Medtronic, Inc. | 1,523 |
| Z2 | Medtronic, Inc. | 955 |
| Vista Brite TIP | Cordis Corp. | 789 |
| Mach1™ | Boston Scientific Corporation | 777 |
| Sherpa NX Active | Medtronic, Inc. | 571 |
| Zuma® | Medtronic, Inc. | 569 |
| Convey | Pendracare International B.V. | 532 |
| Taiga | Medtronic, Inc. | 307 |
| RunWay™ | Boston Scientific Corporation | 300 |
| ConcierGE Guiding Excellence™ | Merit Medical Systems, Inc. | 295 |
| Wiseguide™ | Boston Scientific Corporation | 277 |
Showing 12 of 500. All products under Catheter, Percutaneous
Recalls Naming This Product
35 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 | 126,530 | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | UDI-DI | 2024-02-12 | Class I | Process control | Teleflex is initiating this voluntary recall for the above-mentioned products due to reports received indicating a potentially defective component. The complaints received relate to resistance of the guidewire handle/chamber during use. Th | 1,160,470 devices | |
| 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 | 140 | 2021-02-25 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2019-01-10 | Class II | Error in labeling | The product lidstock contains a labelling error. The lidstock states the incorrect priming volume. The priming volumes printed on the extension lines are correct | None (US) | 2020-06-04 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2019-01-10 | Class II | Error in labeling | The product lidstock contains a labelling error. The lidstock states the incorrect priming volume. The priming volumes printed on the extension lines are correct | 45 eaches total (US) | 2020-06-04 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2018-11-14 | Class II | Error in labeling | The lidstock states the incorrect priming volume and flow rates. | 15 in the US | 2020-06-04 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2018-05-11 | Class II | Employee error | The recalling firm has received complaints related to increased resistance encountered when introducing the CVC over the spring wire guide. This may lead to procedural delay, and there may be need of medical intervention by exchanging the c | 1200 | 2020-04-20 |
| 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 | 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 | 2017-10-17 | Class II | Process control | These finished good kits may contain the incorrect Springwire Guide (SWG). | 5,926 total | 2020-04-14 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2017-10-17 | Class II | Process control | These finished good kits may contain the incorrect Springwire Guide (SWG). | 5,926 total | 2020-04-14 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2017-10-17 | Class II | Process control | These finished good kits may contain the incorrect Springwire Guide (SWG). | 5,926 total | 2020-04-14 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2017-10-17 | Class II | Process control | These finished good kits may contain the incorrect Springwire Guide (SWG). | 5,926 total | 2020-04-14 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2017-10-17 | Class II | Process control | These finished good kits may contain the incorrect Springwire Guide (SWG). | 5,926 total | 2020-04-14 |
| 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 in | 2018-09-17 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2017-05-09 | Class II | Packaging | The Arrow CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: -multiple infusions of fluids, medications, or chemothe | 27,485 units distributed in U.S., 4,371 units distributed in | 2018-09-17 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2014-09-18 | Class II | Labeling False and Misleading | Arrow International, Inc. has initiated a voluntary recall for product code AK- 12703, lot number RF3039028 because the label on the outer corrugate is labeled with the incorrect expiration date. All kits packaged within the corrugate are c | 65 | 2014-12-02 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2014-08-06 | Class II | Packaging | The component supplier recalled their 0.9% Sodium Chloride Injection USP BD Posiflush SF Saline Flush Syringe 10mL because some unit packages may exhibit open seals which impact package integrity and potentially product sterility. | 71255 | 2016-10-14 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2013-07-31 | Class II | Labeling Change Control | Arrow is recalling the product due to a labeling inconsistency. One portion of the lidstock states the kit contains a 3-Lumen catheter while the rest of the lidstock correctly identifies the catheter as 2-Lumen. | 156 | 2015-04-28 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2010-11-09 | Not classified | Process control | One lot of product was inadvertently mislabeled with a product lidstock identifying the product as a triple-lumen catheter with product number CV-15703, but a double-lumen catheter with part number CV-16702 was actually packaged in the kit. | 1150 units | 2012-09-29 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2010-10-29 | Not classified | Other | Sterility may be compromised. | 30,200 units | 2012-09-29 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2010-10-29 | Not classified | Other | Sterility may be compromised. | 134,810 units | 2012-09-29 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2010-10-29 | Not classified | Other | Sterility may be compromised. | 110,490 | 2012-09-29 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2010-10-29 | Not classified | Other | Sterility may be compromised. | 40,260 | 2012-09-29 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2010-10-29 | Not classified | Other | Sterility may be compromised. | 12,250 units | 2012-09-29 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2009-06-17 | Not classified | Process design | The spring wire guide is too large in diameter to pass through the needle, dilator and catheter. | 3019 units | 2009-12-03 |
| 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.