510(k) K961707 ยท BSY Catheters, Suction, Tracheobronchial
TRACH-EZE CLOSED VENTILATION SUCTION SYSTEM
| Applicant | Sorenson Critical Care, Salt Lake City UT, US |
| Decision | Substantially Equivalent, Mar 11, 1997 |
| Received | May 2, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961707
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 30, 2003 | Sorenson Medical, Inc. Trach-Eze Closed Suction System Endotracheal Start Kit *** 16F *** REF 220070 *** Catheter Length: 571 mm *** STERILE ***. Terminated |
BSY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.