# Access Vascular, Inc.

- Location (FDA's records): Ballerica, MA
- FDA decisions: 9 (2018–2025): 9 510(k) clearances
- Product codes: LJS (6), FOZ (3)
- 510(k) review time since 2016: median 137 days, against 171 for FDA's reviews in the same codes and years (4 of 8 faster)
- Predicates its devices cite: 12 (9 its own); citations of its devices by later devices: 9 (9 its own)
- Recalls linked to its devices: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Navilyst Medical, Inc.: 2 (https://510kreport.com/company/navilyst-medical)
- Cook, Inc.: 1 (https://510kreport.com/company/cook)

## Its most-cited devices
- K193015: HydroPICC (PICC-142) (2020), cited by 3
- K220772: HydroMID 4F Single Lumen Midline Catheter (2022), cited by 2
- K213550: HydroPICC 5F Dual Lumen Catheter (2022), cited by 2
- K172885: HydroPICC (2018), cited by 1
- K203069: HydroMID (2021), cited by 1

## Recent decisions
- 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 (Aug 1, 2025)
- K251212: Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM)  (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM) (Jul 1, 2025)
- 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) (Mar 27, 2025)
- 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) (Jan 17, 2025)
- K220772: HydroMID 4F Single Lumen Midline Catheter (Dec 7, 2022)
- K213550: HydroPICC 5F Dual Lumen Catheter (May 4, 2022)
- K203069: HydroMID (Feb 8, 2021)
- K193015: HydroPICC (PICC-142) (Feb 20, 2020)

Source page: https://510kreport.com/company/access-vascular