PEDIATRIC CUFFED AND UNCUFFED ET TUBES; STANDARD CUFFED AND UNCUFFED ET TUBES
FDA 510(k) clearance K050803 · decided 2005-06-30
Clearance details
- K-number
- K050803
- Device name
- PEDIATRIC CUFFED AND UNCUFFED ET TUBES; STANDARD CUFFED AND UNCUFFED ET TUBES
- Applicant
- Vitaid, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2005-03-30
- Decision date
- 2005-06-30
- Days to decision
- 92 days
- Clearance type
- Traditional
- Product code
- BTR
- Device class
- 2
- Regulation number
- 868.5730
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Mccordsville, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Kimberly-Clark Microcuff Endotracheal Tube, Pediatric Oral/Nasal Magill, sizes 3.0mm, 3.5m recall (Z-1143-2007) | Kimberly-Clark Corporation | 2007-08-08 |
| Kimberly Clark Microcuff Endotracheal Tube, Pediatric Oral Curved, sizes 3.0mm, 3.5mm, 4.0 recall (Z-1144-2007) | Kimberly-Clark Corporation | 2007-08-08 |
| Microcuff Endotracheal Tube; Pediatric Oral/Nasal Magill: ID Size: 3,0mm, Microcuff Produc recall (Z-1263-06) | Microcuff Gmbh | 2006-07-25 |