Access Vascular, Inc.
FDA 510(k) & PMA Approved Devices — 9 products
Total Devices9
Categories2
Latest FDA decision2025-08-01
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K243458 | HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001302); HydroPICC 4Fr Single Lumen Marked catheter - Maximal Barrier kit (70001304); HydroPICC 5Fr Dual Lumen Marked catheter, 130 cm guidewire - Basic Kit (70002301); HydroPICC 5Fr Dual Lumen Marked catheter, 70 cm guidewire - Basic Kit (70002302); HydroPICC 5Fr Dual Lumen Marked catheter - Maximal Barrier kit (70002304); Hydr | LJS | 2025-08-01 | View |
| 510(k) | K251212 | Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM) | LJS | 2025-07-01 | View |
| 510(k) | K244059 | HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual Lumen Midline Catheter - Max Barrier Kit (70006104); HydroMID 5F Dual Lumen Midline Catheter - Mobile Max Barrier Kit (90006104) | FOZ | 2025-03-27 | View |
| 510(k) | K243941 | HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001202); HydroPICC 4Fr Single Lumen Marked catheter, Maximal Barrier kit (70001204); HydroPICC 4Fr Single Lumen Marked catheter, Mobile Maximal Barrier Kit (90001204) | LJS | 2025-01-17 | View |
| 510(k) | K220772 | HydroMID 4F Single Lumen Midline Catheter | FOZ | 2022-12-07 | View |
| 510(k) | K213550 | HydroPICC 5F Dual Lumen Catheter | LJS | 2022-05-04 | View |
| 510(k) | K203069 | HydroMID | FOZ | 2021-02-08 | View |
| 510(k) | K193015 | HydroPICC (PICC-142) | LJS | 2020-02-20 | View |
| 510(k) | K172885 | HydroPICC | LJS | 2018-02-20 | View |
No matching devices.