VITAL-PORT VASC ACCESS 901OP/911OP/9012P/9112P
FDA 510(k) clearance K924748 · decided 1993-07-28
Clearance details
- K-number
- K924748
- Device name
- VITAL-PORT VASC ACCESS 901OP/911OP/9012P/9112P
- Applicant
- Med Institute, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-09-22
- Decision date
- 1993-07-28
- Days to decision
- 309 days
- Clearance type
- Traditional
- Product code
- LJT
- Device class
- 2
- Regulation number
- 880.5965
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- West Lafayette, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Vital Port Vascular Access System Polysulfone Petite with detached 0.9mm catheter recall (Z-2190-2008) | Cook Vascular Inc. | 2008-09-17 |
| Vital Port Vascular Access System Polysulfone Petite with detached 1.0mm catheter recall (Z-2191-2008) | Cook Vascular Inc. | 2008-09-17 |