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Access Vascular, Inc.

FDA 510(k) & PMA Approved Devices — 9 products

Total Devices9
Categories2
Latest Approval2025-08-01
TypeNumberDevice NameCodeDate
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