CLAMPLESS VALVED CATHETER
FDA 510(k) clearance K962300 · decided 1996-09-05
Clearance details
- K-number
- K962300
- Device name
- CLAMPLESS VALVED CATHETER
- Applicant
- Bmw Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-06-13
- Decision date
- 1996-09-05
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- LJS
- Device class
- 2
- Regulation number
- 880.5970
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Murray, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Silicone Central Venous Catheter with PASV Valve and Polyester Cuff - 6.6F. Boston Scienti recall (Z-0341-06) | Boston Scientific Corporation | 2006-01-06 |
| Silicone Central Venous Catheters with PASV Valve and Polyester Cuff - 7F. Boston Scientif recall (Z-0342-06) | Boston Scientific Corporation | 2006-01-06 |
| Tunneled Central Venous Catheters With PASV Valve Technology And Polyester Cuff - PASV CVC recall (Z-1509-05) | Boston Scientific Corporation | 2005-09-02 |
| Tunneled Central Venous Catheters With PASV Valve Technology And Polyester Cuff - PASV CVC recall (Z-1510-05) | Boston Scientific Corporation | 2005-09-02 |
| Tunneled Central Venous Catheters With PASV Valve Technology And Polyester Cuff - PASV CVC recall (Z-1511-05) | Boston Scientific Corporation | 2005-09-02 |