BIVONA FOME-CUF(R) & AIR CUF(R), MODIFICATION
FDA 510(k) clearance K913859 · decided 1992-01-30
Clearance details
- K-number
- K913859
- Device name
- BIVONA FOME-CUF(R) & AIR CUF(R), MODIFICATION
- Applicant
- Bivona Medical Technologies
- Decision
- Substantially Equivalent
- Date received
- 1991-08-27
- Decision date
- 1992-01-30
- Days to decision
- 156 days
- Clearance type
- Traditional
- Product code
- JOH
- Device class
- 2
- Regulation number
- 868.5800
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Gary, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Bivona Adult Tracheostomy Tube, I.D. 8.5 mm, O.D 11.0 mm, Length 88 mm, TTS 11.8 mm, Mfrd recall (Z-0339-2007) | Smiths Medical ASD, Inc. | 2007-01-05 |
| Bivona Adult Tracheostomy Tube, Labeled I.D. 6.0 mm, O.D. 8.7 mm, A 7.0 mm, B 0 mm, C 53.0 recall (Z-0046-2007) | Smiths Medical ASD, Inc. | 2006-10-19 |