Access Vascular, Inc.
Access Vascular, Inc. holds FDA 510(k) medical device clearances, first cleared 2018, most recent 2025, with 9 FDA device recalls on record.
Top product codes for Access Vascular, Inc.
FDA recalls by Access Vascular, Inc.
- Z-0115-2024 — HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004
- Z-0114-2024 — HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80002002
- Z-1605-2023 — HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004
- Z-1156-2023 — HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy Product Number: 80004004
- Z-1155-2023 — HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy Product Model Number: 80004004
- Z-1130-2023 — HydroPICC 4Fr Single Lumen, 80cm Guidewire - Basic Kit, Model Number 80001002
- Z-1129-2023 — HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002
- Z-1131-2023 — HydroPICC 4Fr Single Lumen, 130cm Guidewire - Basic Kit, Model Number 80001001
- Z-0199-2023 — Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripherally Inserted Central Catheter
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Access Vascular, Inc.
- K243458 — HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301) +5 more
- K251212 — Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)
- K244059 — HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102) +2 more
- K243941 — HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201) +3 more
- K220772 — HydroMID 4F Single Lumen Midline Catheter
- K213550 — HydroPICC 5F Dual Lumen Catheter
- K203069 — HydroMID
- K193015 — HydroPICC (PICC-142)
- K172885 — HydroPICC
Data sourced from openFDA. This site is unofficial and independent of the FDA.