CATHETER, VEIN (VENOFIX)
FDA 510(k) clearance K760388 · decided 1976-11-02
Clearance details
- K-number
- K760388
- Device name
- CATHETER, VEIN (VENOFIX)
- Applicant
- B. Braun Instruments
- Decision
- Substantially Equivalent
- Date received
- 1976-08-05
- Decision date
- 1976-11-02
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- DQO
- Device class
- 2
- Regulation number
- 870.1200
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| WHIN Infusion Set - 90 Huber Needle and Wing (22 ga/1in). Intravenous delivery through int recall (Z-1703-2016) | B. Braun Medical, Inc. | 2016-05-20 |