510(k) K171912 ยท DQX Wire, Guide, Catheter
Double Flexible Tip Wire Guides
| Applicant | Cook Incorporated, Bloomington IN, US |
| Decision | Substantially Equivalent, Mar 19, 2018 |
| Received | Jun 26, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171912
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 28, 2022 | Cook Incorporated Double Flexible Tipped Wire Guide, Guidewire
Reference Part Number/GPN
TDOC-35-145-0-3 G00362
C-TDOC-18-50-0-2 G05146
TDOC-35-50-0-3 G00364
C-DOC-21-40-0-2 G02431
C-TDOC-21-50-0-2 G05195
C-TDOC-25-50- Open, Classified |
DQX | None listed |
| Sep 28, 2022 | Cook Incorporated Heavy Double Flexible Tipped Wire Guide, Guidewire
Reference Part Number/GPN:
THDOC-35-60-0-3 G11949
C-HDOC-18-40-0-2 G09201
C-THDOC-18-40-0-2-HTS G26925 Open, Classified |
DQX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.