Medical Device Manufacturer · US , Bedford , MA

Access Vascular, Inc. - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 2018

Recent clearances: HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301), Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM), HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102)

9

Total

9

Cleared

0

Denied

FDA 510(k) Regulatory Record - Access Vascular, Inc. General Hospital ✕

9 devices

1-9 of 9

Cleared Aug 01, 2025

HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit...

General Hospital · 266d

Cleared Jul 01, 2025

Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM)

General Hospital · 74d

Cleared Mar 27, 2025

HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102)

General Hospital · 86d

Cleared Jan 17, 2025

HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit...

General Hospital · 28d

Cleared Dec 07, 2022

HydroMID 4F Single Lumen Midline Catheter

General Hospital · 266d

Cleared May 04, 2022

HydroPICC 5F Dual Lumen Catheter

General Hospital · 177d

Cleared Feb 08, 2021

General Hospital · 122d

Cleared Feb 20, 2020

HydroPICC (PICC-142)

General Hospital · 114d

Cleared Feb 20, 2018

General Hospital · 152d