510(k) K050803 ยท BTR Tube, Tracheal (W/Wo Connector)
PEDIATRIC CUFFED AND UNCUFFED ET TUBES; STANDARD CUFFED AND UNCUFFED ET TUBES
| Applicant | Vitaid, Ltd., Mccordsville IN, US |
| Decision | Substantially Equivalent, Jun 30, 2005 |
| Received | Mar 30, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050803
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 8, 2007 | Kimberly-Clark Corporation Kimberly-Clark Microcuff Endotracheal Tube, Pediatric Oral/Nasal Magill, sizes 3.0mm, 3.5mm, 4.0mm, and 4.5mm, Rx Only, Sterile, Manufacturer: Kimberly-Clark NV Belgicastraat 13, 1930 Zaventem, Belgiu Terminated |
BTR | None listed |
| Aug 8, 2007 | Kimberly-Clark Corporation Kimberly Clark Microcuff Endotracheal Tube, Pediatric Oral Curved, sizes 3.0mm, 3.5mm, 4.0mm and 4.5mm, Rx Only, Sterile, Manufacturer: Kimberly-Clark NV Belgicastraat 13, 1930 Zaventem, Belgium, Made Terminated |
BTR | None listed |
| Jul 25, 2006 | Microcuff Gmbh Microcuff Endotracheal Tube; Pediatric Oral/Nasal Magill:
ID Size: 3,0mm, Microcuff Product Reference: I-MPEDC-30;
ID Size: 3,5mm, Product Reference: I-MPEDC-35;
ID Size: 4,0mm, Product Reference: Terminated |
BTR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.