SILICONE FOAM CUFF TRACHEOSTOMY TUBES, SILICONE CUFFLESS NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES
FDA 510(k) clearance K031553 · decided 2003-11-18
Clearance details
- K-number
- K031553
- Device name
- SILICONE FOAM CUFF TRACHEOSTOMY TUBES, SILICONE CUFFLESS NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES
- Applicant
- Arcadia Medical Corporation
- Decision
- Substantially Equivalent
- Date received
- 2003-05-19
- Decision date
- 2003-11-18
- Days to decision
- 183 days
- Clearance type
- Traditional
- Product code
- BTO
- Device class
- 2
- Regulation number
- 868.5800
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Appollo Beach, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Silicone Cuffed Wire Reinforced Extended Connect Pediatric Perfect Fit Neck Flange Tracheo recall (Z-1628-2012) | Arcadia Medical Corporation | 2012-05-21 |
| Silicone CTS (Close to Shaft) Cuff Adjustable Neck Flange Tracheostomy Tube (Wire Reinforc recall (Z-2657-2011) | Arcadia Medical Corporation | 2011-06-24 |