510(k) K091385 ยท DQX Wire, Guide, Catheter
APPROACH HYDRO ST WIRE GUIDE, MODEL HMW
| Applicant | Cook, Inc., Bloomington IN, US |
| Decision | Substantially Equivalent, Aug 7, 2009 |
| Received | May 10, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K091385
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 8, 2024 | Cook Incorporated Approach Hydro ST Micro Wire Guide; Catalog prefix HMW
Reference Part Numbers:
HMW-14-135-ST
HMW-14-190-ST
HMW-14-300-ST Open, Classified |
DQX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.