510(k) K041348 ยท JOH Tube Tracheostomy And Tube Cuff
PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT_WITH SERIAL DILATORS OR SINGLE STAGE DILATOR, BLUE LINE ULTRA
| Applicant | Smiths Medical, Hythe, Kent, GB |
| Decision | Substantially Equivalent, Jul 13, 2004 |
| Received | May 20, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041348
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 14, 2021 | Smiths Medical ASD Inc. PORTEX UNLTRperc Percutaneous Dilation Tracheostomy Kit, REF 100/596/090 - Product Usage: intended for use in a controlled setting such as an Intensive Care Unit or operating room with the assistance Terminated |
JOH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.