CLAMPLESS VALVED CATHETER - TUNNELED (CVC-T)
FDA 510(k) clearance K963806 · decided 1996-12-12
Clearance details
- K-number
- K963806
- Device name
- CLAMPLESS VALVED CATHETER - TUNNELED (CVC-T)
- Applicant
- Bmw Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-09-23
- Decision date
- 1996-12-12
- Days to decision
- 80 days
- Clearance type
- Traditional
- Product code
- LJS
- Device class
- 2
- Regulation number
- 880.5970
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Tunneled Central Venous Catheters With PASV Valve Technology And Polyester Cuff - PASV CVC recall (Z-1508-05) | Boston Scientific Corporation | 2005-09-02 |
| PASV Central Venous Catheter, 7F, Cat. # CVC702IK, Model # M0001CVC702IK. The 7Fr PASV Cen recall (Z-1112-05) | Boston Scientific Corporation | 2005-08-10 |