Arrow
You-Bend(TM) Two-Lumen Hemodialysis Catheterization Set with Blue Flextip(R) Catheter for High Volume Infusions
1manufacturer
45catalogue numbers in this listing
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
Record
| Listed by | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | LFJ |
| Device type | Catheter, Subclavian |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5540 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K895417 |
| Record published | 2017-08-02 |
| Record revised | 2023-06-07 (version 12) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| 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 |
| Sizes | Catheter gauge 12 Fr; length 13 to 20 cm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN033906 | Catheter Gauge 12 Fr | In distribution |
| IPN036966 | In distribution | |
| IPN928091 | In distribution | |
| IPN038487 | In distribution | |
| IPN931139 | In distribution | |
| IPN036965 | In distribution | |
| IPN030087 | In distribution | |
| IPN919725 | In distribution | |
| IPN919948 | In distribution | |
| IPN032656 | Catheter Gauge 12 Fr | In distribution |
| IPN033927 | Catheter Gauge 12 Fr | In distribution |
| IPN032656 | Length 20 cm | In distribution |
| IPN036966 | In distribution | |
| IPN036965 | In distribution | |
| IPN032654 | Length 20 cm | In distribution |
| IPN931138 | In distribution | |
| IPN919704 | In distribution | |
| IPN931137 | In distribution | |
| IPN928087 | In distribution | |
| IPN033927 | Catheter Gauge 12 Fr | In distribution |
| IPN926656 | In distribution | |
| IPN919709 | In distribution | |
| IPN030091 | Catheter Gauge 12 Fr | In distribution |
| IPN919710 | In distribution | |
| IPN033927 | Catheter Gauge 12 Fr | In distribution |
| IPN030088 | Length 20 cm | In distribution |
| IPN033906 | In distribution | |
| IPN032655 | Catheter Gauge 12 Fr | In distribution |
| IPN030065 | Length 20 cm | In distribution |
| IPN030848 | Catheter Gauge 12 Fr | In distribution |
| IPN032653 | Catheter Gauge 12 Fr | In distribution |
| IPN919724 | In distribution | |
| IPN032655 | Length 20 cm | In distribution |
| IPN030064 | Catheter Gauge 12 Fr | In distribution |
| IPN036966 | In distribution | |
| IPN030847 | Catheter Gauge 12 Fr | In distribution |
| IPN036182 | In distribution | |
| IPN033906 | Length 16 cm | In distribution |
| IPN030872 | Length 13 cm | In distribution |
| IPN926657 | In distribution | |
| IPN032654 | Catheter Gauge 12 Fr | In distribution |
| IPN919711 | In distribution | |
| IPN030845 | Length 16 cm | In distribution |
| IPN030063 | In distribution | |
| IPN036965 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hemo-Cath® | Medical Components Inc | 37 |
| SLX Hemo-Cath® | Medical Components Inc | 28 |
| Permcath | Mozarc Medical US LLC | 9 |
| Silicone Hemo-Cath-NO Cuff/Acutesilicone Hemo-Cath-NO Cuff/Acute | Medical Components Inc | 6 |
| Brevia Short Term Dialysis Catheter | Bard Access Systems, Inc. | 4 |
| Mahurkar | Mozarc Medical US LLC | 4 |
| Argyle | Mozarc Medical US LLC | 4 |
| Brevia Dialysis Catheter Kit | Bard Access Systems, Inc. | 4 |
| Schon | AngioDynamics, Inc. | 4 |
| Hemo-Cath® Silicone | Medical Components Inc | 3 |
| Hemo-Cath®ij | Medical Components Inc | 2 |
| Soft-Cell Dialysis Catheter Kit 12.5 F x 19 cm | Bard Access Systems, Inc. | 1 |
Showing 12 of 25. All products under Catheter, Subclavian
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| 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 | 1,945 |
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.