BIVONA CUSTOMIZED TRACHEOSTOMY TUBES
FDA 510(k) clearance K923878 · decided 1992-12-29
Clearance details
- K-number
- K923878
- Device name
- BIVONA CUSTOMIZED TRACHEOSTOMY TUBES
- Applicant
- Bivona Medical Technologies
- Decision
- Substantially Equivalent
- Date received
- 1992-08-03
- Decision date
- 1992-12-29
- Days to decision
- 148 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 |
|---|---|---|
| Custom 5.5 mm Bivona Uncuffed Hyperflex Tracheostomy Tube, I.D. 5.5 mm, O.D. 8.0 mm, lengt recall (Z-0260-2007) | Smiths Medical ASD, Inc. | 2006-12-07 |