510(k) K133597 ยท JOH Tube Tracheostomy And Tube Cuff
CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY
| Applicant | Cook, Inc., Bloomington IN, US |
| Decision | Substantially Equivalent, Apr 18, 2014 |
| Received | Nov 22, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133597
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 6, 2026 | Cook Incorporated COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-FLEX-HC, Order Number G32092;
Reference Part Number C-PTIS-100-HC, Order Number G12115. Open, Classified |
JOH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.