LOW PROFILE TRACHEOSTOMY TUBE
FDA 510(k) clearance K922749 · decided 1992-09-02
Clearance details
- K-number
- K922749
- Device name
- LOW PROFILE TRACHEOSTOMY TUBE
- Applicant
- Concord/Portex
- Decision
- Substantially Equivalent
- Date received
- 1992-06-08
- Decision date
- 1992-09-02
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- BTO
- Device class
- 2
- Regulation number
- 868.5800
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Keene, NH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Portex Tracheostomy Tube Decannulation Cap for use only with Fenestrated Tracheostomy Tube recall (Z-0228-05) | Smiths Medical ASD, Inc. | 2004-11-24 |
| Portex Lo-Profile Tracheostomy Tube Decannulation Cap Catalog Number: 582000 recall (Z-0229-05) | Smiths Medical ASD, Inc. | 2004-11-24 |
| Lo-Profile Fenestrated Tracheostomy Tube, Cuffed and Fenestrated Tube I.D. 9.0mm Catalog N recall (Z-1039-03) | Portex Inc. | 2003-07-23 |