510(k) K171897 ยท DQX Wire, Guide, Catheter
Approach CTO Microwire Guide
| Applicant | Cook Incorporated, Bloomington IN, US |
| Decision | Substantially Equivalent, Aug 21, 2017 |
| Received | Jun 26, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171897
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 6, 2026 | Cook Incorporated COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-190-6G, Order Number G50786 Open, Classified |
DQX | None listed |
| Nov 21, 2024 | Cook Incorporated Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789 Open, Classified |
DQX | None listed |
| Nov 8, 2024 | Cook Incorporated Approach CTO Micro Wire Guide, Guide Wire, Catalog Prefix CMW;
Reference Part Numbers:
CMW-14-190-12G
CMW-14-190-18G
CMW-14-190-25G
CMW-14-190-6G
CMW-14-300-12G
CMW-14-300-18G
CMW-14-300-25G
CMW-14-3 Open, Classified |
DQX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.