510(k) K962175 ยท JOH Tube Tracheostomy And Tube Cuff
PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE
| Applicant | Smiths Industries Medical Systems, Inc., Keene NH, US |
| Decision | Substantially Equivalent, Jan 17, 1997 |
| Received | Jun 5, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962175
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 14, 2017 | Smiths Medical ASD Inc. UniPerc(R) Adjustable Flange Tracheostomy Tube kit, Reorder Number 100/897/080 CZ
The UniPerc(R) Tracheostomy Tubes can be used during the surgical placement of a stoma or as a replacement tube t Terminated |
JOH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.