Arrow
Arrow(R) VPS(R) Access Kit for use with 4.5 Fr. Peripherally Inserted Central Venous Catheter
4manufacturers in China registered for this device type
27catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Philips Ultrasound (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 5 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Jiangsu Tingsn Technology Co., Ltd. | Nanjing | Jiangsu | Manufacturer | 4 |
| Nanjing Shuangwei Biotechnology Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 1 |
Record
| Listed by | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | OBJ |
| Device type | Catheter, Ultrasound, Intravascular |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1200 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K103255 |
| Record published | 2019-12-20 |
| Record revised | 2025-11-20 (version 12) |
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 |
| Storage | Storage environment temperature 20 to 25 °C |
| Packaging | Case of 3, case, case of 8, box, case of 5, case of 40 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN056265 | In distribution | |
| IPN929361 | In distribution | |
| IPN035995 | In distribution | |
| IPN037886 | In distribution | |
| IPN925158 | In distribution | |
| IPN036055 | In distribution | |
| IPN055895 | In distribution | |
| IPN926213 | In distribution | |
| IPN037338 | In distribution | |
| IPN035995 | In distribution | |
| IPN035993 | In distribution | |
| IPN035977 | In distribution | |
| IPN929360 | In distribution | |
| IPN035976 | In distribution | |
| IPN922601 | In distribution | |
| IPN056264 | In distribution | |
| IPN925159 | In distribution | |
| IPN035990 | In distribution | |
| IPN035985 | In distribution | |
| IPN037703 | In distribution | |
| IPN035973 | In distribution | |
| IPN039773 | In distribution | |
| IPN036776 | In distribution | |
| IPN036054 | In distribution | |
| IPN034231 | In distribution | |
| IPN926119 | In distribution | |
| IPN037341 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Acist HDi® HD Ivus System | Acist Medical Systems, Inc. | 8 |
| Soundstar | Biosense Webster, Inc. | 6 |
| OptiCross | Boston Scientific Corporation | 4 |
| Busse Hospital Disposables | Robert Busse & Co., Inc. | 4 |
| Acist HDi® System Console | Acist Medical Systems, Inc. | 4 |
| OptiCross™ 6 | Boston Scientific Corporation | 3 |
| 7 Fr PV-Catheter | CD Leycom | 3 |
| NES Reprocessed Visions PV.014P RX Digital Ivus Catheter | North East Scientific Inc | 3 |
| OptiCross™ 6 HD | Boston Scientific Corporation | 2 |
| Acist HDi® Bed Rail Mount | Acist Medical Systems, Inc. | 2 |
| 4 Fr PV Catheter | CD Leycom | 2 |
| Eagle Eye Platinum RX Digital Ivus Catheter | Philips Image Guided Therapy Corporation | 2 |
Showing 12 of 63. All products under Catheter, Ultrasound, Intravascular
Recalls Naming This Product
4 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 | 2017-06-01 | Class II | Mixed-up of materials/components | There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths. | 2020-04-13 | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2017-04-28 | Class II | Unknown/Undetermined by firm | Arrow International is notifying each customer who received the affected that product that the kits do not contain important information regarding the 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing. | 3,918 units | 2018-08-03 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2015-07-30 | Class II | Under Investigation by firm | saline leakage from unsecured connections between the Touhy Borst adaptor and the hub of the catheter. No injuries reported. | 92902 | 2018-02-26 |
| Teleflex Medical LLC | 510(k) number | 2015-03-30 | Class II | Device Design | A limited number of VPS G4 Consoles are being recalled due to noncompliance with International Electrotechnical Commission Standard 60101-1-1. | 17 | 2016-04-11 |
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.