Medical Device Manufacturer · US , Bedford , MA

Access Vascular, Inc.

9 submissions · 9 cleared · Since 2018
9
Total
9
Cleared
0
Denied

Access Vascular, Inc. — FDA 510(k) Submissions

Access Vascular, Inc. has submitted 9 FDA 510(k) premarket notifications since 2018, of which 9 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days, Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days . Use the specialty filter in the sidebar to narrow results.

9 devices
1–9 of 9
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
K243458 · LJS Catheter, Intravascular,... · General Hospital
Aug 2025 266d
Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)
K251212 · LJS Catheter, Intravascular,... · General Hospital
Jul 2025 74d
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)
K244059 · FOZ Catheter, Intravascular,... · General Hospital
Mar 2025 86d
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)
K243941 · LJS Catheter, Intravascular,... · General Hospital
Jan 2025 28d
HydroMID 4F Single Lumen Midline Catheter
K220772 · FOZ Catheter, Intravascular,... · General Hospital
Dec 2022 266d
HydroPICC 5F Dual Lumen Catheter
K213550 · LJS Catheter, Intravascular,... · General Hospital
May 2022 177d
HydroMID
K203069 · FOZ Catheter, Intravascular,... · General Hospital
Feb 2021 122d
HydroPICC (PICC-142)
K193015 · LJS Catheter, Intravascular,... · General Hospital
Feb 2020 114d
HydroPICC
K172885 · LJS Catheter, Intravascular,... · General Hospital
Feb 2018 152d
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