510(k) K031553 ยท BTO Tube, Tracheostomy (W/Wo Connector)
SILICONE FOAM CUFF TRACHEOSTOMY TUBES, SILICONE CUFFLESS NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES
| Applicant | Arcadia Medical Corporation, Appollo Beach FL, US |
| Decision | Substantially Equivalent, Nov 18, 2003 |
| Received | May 19, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031553
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 21, 2012 | Arcadia Medical Corporation Silicone Cuffed Wire Reinforced Extended Connect Pediatric Perfect Fit Neck Flange Tracheostomy Tube, Size 4.0 mm I.D. Catalog Number 353-040.
Intended for use in providing direct tracheal access fo Terminated |
BTO | None listed |
| Jun 24, 2011 | Arcadia Medical Corporation Silicone CTS (Close to Shaft) Cuff Adjustable Neck Flange Tracheostomy Tube (Wire Reinforced), Arcadia Medical Silicone Air Cuff Adjustable Tracheostomy Tube, Sterile, Latex-Free,
Provides direct tr Terminated |
BTO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.