510(k) K171997 ยท DQX Wire, Guide, Catheter
Mandril Wire Guide
| Applicant | Cook Incorporated, Bloomington IN, US |
| Decision | Substantially Equivalent, Mar 30, 2018 |
| Received | Jul 3, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171997
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 28, 2022 | Cook Incorporated Cope Mandril Wire Guide (Nitinol), Nitinol Guidewire;
Reference Part Number/GPN:
PMG-18SP-60-COPE-NT-ST G09395
PMG-18SP-100-COPE-NT G08687
PMG-18SP-60-COPE-NT G08427 Open, Classified |
DQX | None listed |
| Sep 28, 2022 | Cook Incorporated Cope Mandril Wire Guide (Stainless Steel), Stainless Steel Guidewire
Reference Part Number/GPN
PMG-18SP-60-COPE G05183
PMG-18SP-100-COPE G05822
PMG-18SP-125-COPE G10077 Open, Classified |
DQX | None listed |
| Sep 28, 2022 | Cook Incorporated Torq-Flex Wire Guide Australian Modification, Guidewire
Reference Part Number/GPN
STF-18-40-AUST G07304 Open, Classified |
DQX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.