BIVONA HYPERFLEX TRACHEOSTOMY TUBE
FDA 510(k) clearance K922665 · decided 1993-01-07
Clearance details
- K-number
- K922665
- Device name
- BIVONA HYPERFLEX TRACHEOSTOMY TUBE
- Applicant
- Bivona Medical Technologies
- Decision
- Substantially Equivalent
- Date received
- 1992-06-01
- Decision date
- 1993-01-07
- Days to decision
- 220 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 brand Mid-Range Aire-Cuf Adjustable Neck Flange Hyperflex Tracheostomy Tube, I.D. 6 recall (Z-0394-06) | Smiths Medical ASD, Inc. | 2006-01-18 |
| Bivona brand Mid-Range Aire-Cuf Extra Length Fixed Hyperflex Adult Tracheostomy Tube, I.D. recall (Z-0395-06) | Smiths Medical ASD, Inc. | 2006-01-18 |
| Bivona brand TTS Adjustable Neck Flange Hyperflex Tracheostomy Tube, I.D. 8.0 mm O.D. 11.0 recall (Z-0396-06) | Smiths Medical ASD, Inc. | 2006-01-18 |
| Bivona brand Cuffless Extra Length Fixed Hyperflex Adult Tracheostomy Tube, 110 mm, steril recall (Z-0338-06) | Smiths Medical ASD, Inc. | 2006-01-06 |
| Bivona brand Adjustable Hyperflex Tracheostomy Tube, Pediatric, cuffless; catalog # 60HA40 recall (Z-0927-03) | Portex, Inc | 2003-06-12 |