HydroPICC (PICC-142)
FDA 510(k) clearance K193015 · decided 2020-02-20
Clearance details
- K-number
- K193015
- Device name
- HydroPICC (PICC-142)
- Applicant
- Access Vascular, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-10-29
- Decision date
- 2020-02-20
- Days to decision
- 114 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 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004 recall (Z-1605-2023) | Access Vascular, Inc | 2023-05-18 |
| HydroPICC 4Fr Single Lumen, 80cm Guidewire - Basic Kit, Model Number 80001002 recall (Z-1130-2023) | Access Vascular, Inc | 2023-02-10 |
| HydroPICC 4Fr Single Lumen, 130cm Guidewire - Basic Kit, Model Number 80001001 recall (Z-1131-2023) | Access Vascular, Inc | 2023-02-10 |
| Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripherally Inserte recall (Z-0199-2023) | Access Vascular, Inc. | 2022-11-08 |