510(k) K181351 ยท DQX Wire, Guide, Catheter
Double Flexible Tipped Wire Guides
| Applicant | Cook Incorporated, Bloomington IN, US |
| Decision | Substantially Equivalent, Jun 14, 2018 |
| Received | May 22, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K181351
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.