Arrow
Single-Lumen Infusion Catheter (SLIC(R)) for use with Arrow Percutaneous Sheath Introducer System
33manufacturers in China registered for this device type
23catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (18), Zhejiang (9), Guangdong (3). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Principle & Will Biotech (Pinghu) Co., Ltd. | Pinghu | Zhejiang | Contract manufacturer | 39 |
| Ningbo Luke Medical Devices Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 27 |
| Conod Medical Shuyang Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 22 |
| Changzhou DSB Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 16 |
| Alleva Medical (D.G.) Ltd | Dongguan | Guangdong | Contract manufacturer | 13 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Guangzhou Nuoning Medical Supplies Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 62 |
Showing 12 of 33. All 33 manufacturers in China registered for Accessories, Catheter
Record
| Listed by | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | KGZ |
| Device type | Accessories, Catheter |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4200 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K781846 |
| Record published | 2016-09-16 |
| Record revised | 2026-05-18 (version 9) |
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 | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 25, box of 25, case of 2 |
| Distribution end date | 2025-09-12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN032546 | In distribution | |
| IPN032958 | In distribution | |
| IPN036257 | In distribution | |
| IPN032953 | In distribution | |
| IPN920679 | In distribution | |
| IPN033596 | In distribution | |
| IPN033595 | In distribution | |
| IPN032959 | In distribution | |
| IPN032955 | In distribution | |
| IPN035945 | In distribution | |
| IPN032957 | In distribution | |
| IPN032956 | In distribution | |
| IPN924132 | In distribution | |
| IPN920676 | In distribution | |
| IPN036256 | In distribution | |
| IPN921171 | In distribution | |
| IPN032954 | In distribution | |
| IPN920675 | In distribution | |
| IPN924134 | In distribution | |
| IPN032960 | In distribution | |
| IPN921170 | In distribution | |
| IPN054588 | In distribution | |
| IPN032545 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MedDrain | Armm, Inc. | 77 |
| Silicone Drainage Tube | Fortune Medical Instrument Corp. | 74 |
| Typenex Wound Drainage | Typenex Medical, LLC | 56 |
| Cook | Cook Incorporated | 49 |
| Marina Medical | Marina Medical Instruments, Inc. | 48 |
| Curaplex | Bound Tree Medical, LLC | 36 |
| Mediplus | Mediplus Ltd. | 29 |
| AlliedSil™ Silicone Tubing | Implantech Associates, Inc. | 24 |
| Silicone Thoracic Catheters | Atrium Medical Corporation | 21 |
| Neff | Cook Incorporated | 18 |
| Silhouette | Cook Incorporated | 16 |
| Argyle | Cardinal Health | 16 |
Showing 12 of 111. All products under Accessories, Catheter
Recalls Naming This Product
3 recalls name this product by its own identifiers, 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 | 2010-06-07 | Not classified | Process change control | Sterility not assured. The stopcock handle position was inadvertently changed from an open to a closed position, which prevents sterilization of the closed portion of the device. Sterility of the affected product cannot be guaranteed. | 3000 kits | 2012-09-29 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2009-12-15 | Not classified | Packaging | Some central venous catheter sets had the incorrect lid stock. | 295 kits | 2011-07-29 |
| 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.