Access Vascular, Inc.
FDA Regulatory Profile
Access Vascular, Inc. appears in FDA public data with 9 recalls, 9 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0115-2024, Class II) was initiated on August 31, 2023. Its most recent 510(k) clearance was granted on August 1, 2025.
Summary
- Total Recalls
- 9
- 510(k) Clearances
- 9
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0115-2024 | Class II | HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004 | August 31, 2023 |
| Z-0114-2024 | Class II | HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80002002 | August 31, 2023 |
| Z-1605-2023 | Class II | HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004 | March 3, 2023 |
| Z-1155-2023 | Class II | HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term access (<30days) to the pe | December 22, 2022 |
| Z-1156-2023 | Class II | HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term access (<30days) to the per | December 22, 2022 |
| Z-1129-2023 | Class II | HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002 | December 16, 2022 |
| Z-1130-2023 | Class II | HydroPICC 4Fr Single Lumen, 80cm Guidewire - Basic Kit, Model Number 80001002 | December 16, 2022 |
| Z-1131-2023 | Class II | HydroPICC 4Fr Single Lumen, 130cm Guidewire - Basic Kit, Model Number 80001001 | December 16, 2022 |
| Z-0199-2023 | Class II | Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripherally Inserted Central | February 24, 2021 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K243458 | HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr S | August 1, 2025 |
| K251212 | Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PIC | July 1, 2025 |
| K244059 | HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual Lumen Midline Cathe | March 27, 2025 |
| K243941 | HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201); HydroPICC 4Fr | January 17, 2025 |
| K220772 | HydroMID 4F Single Lumen Midline Catheter | December 7, 2022 |
| K213550 | HydroPICC 5F Dual Lumen Catheter | May 4, 2022 |
| K203069 | HydroMID | February 8, 2021 |
| K193015 | HydroPICC (PICC-142) | February 20, 2020 |
| K172885 | HydroPICC | February 20, 2018 |