HydroPICC 5F Dual Lumen Catheter
FDA 510(k) clearance K213550 · decided 2022-05-04
Clearance details
- K-number
- K213550
- Device name
- HydroPICC 5F Dual Lumen Catheter
- Applicant
- Access Vascular, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-11-08
- Decision date
- 2022-05-04
- Days to decision
- 177 days
- Clearance type
- Traditional
- Product code
- LJS
- Device class
- 2
- Regulation number
- 880.5970
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Bedford, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80002002 recall (Z-0114-2024) | Access Vascular, Inc | 2023-10-13 |
| HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004 recall (Z-0115-2024) | Access Vascular, Inc | 2023-10-13 |