Access Vascular, Inc.
Medical device manufacturer in Ballerica, MA.
9510(k) clearances
0PMA approvals
9recalls
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K243458 | HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301)…LJS · Traditional | 08/01/2025SE |
| K251212 | Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC…LJS · Special | 07/01/2025SE |
| K244059 | HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual Lumen…FOZ · Special | 03/27/2025SE |
| K243941 | HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201)…LJS · Special | 01/17/2025SE |
| K220772 | HydroMID 4F Single Lumen Midline CatheterFOZ · Traditional | 12/07/2022SE |
| K213550 | HydroPICC 5F Dual Lumen CatheterLJS · Traditional | 05/04/2022SE |
| K203069 | HydroMIDFOZ · Abbreviated | 02/08/2021SE |
| K193015 | HydroPICC (PICC-142)LJS · Traditional | 02/20/2020SE |
| K172885 | HydroPICCLJS · Traditional | 02/20/2018SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0115-2024 Class II | HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004Specific lots of the Dual Lumen HydroPICC Kits were provided with the incorrect revision of the Instructions… | 08/31/2023Open, Classified |
| Z-0114-2024 Class II | HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80002002Specific lots of the Dual Lumen HydroPICC Kits were provided with the incorrect revision of the Instructions… | 08/31/2023Open, Classified |
| Z-1605-2023 Class II | HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004The catheter packaged with specific lots of the HydroPICC Kits and HydroMID Kits have a shorter expiration… | 03/03/2023Open, Classified |
| Z-1156-2023 Class II | HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term access (<30days)…Label with the incorrect component listed on the inner kit Tyvek header bag | 12/22/2022Open, Classified |
| Z-1155-2023 Class II | HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term access (<30days)…Product Mislabeled on the outer bag and inner kit Tyvek header bag | 12/22/2022Open, Classified |
| Z-1131-2023 Class II | HydroPICC 4Fr Single Lumen, 130cm Guidewire - Basic Kit, Model Number 80001001Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters… | 12/16/2022Open, Classified |
| Z-1130-2023 Class II | HydroPICC 4Fr Single Lumen, 80cm Guidewire - Basic Kit, Model Number 80001002Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters… | 12/16/2022Open, Classified |
| Z-1129-2023 Class II | HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters… | 12/16/2022Open, Classified |
| Z-0199-2023 Class II | Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripherally…Scalpel and StatLock components packaged with specific lots of the HydroPICC catheter have a shorter… | 02/24/2021Terminated |