510(k) K162448 ยท DQO Catheter, Intravascular, Diagnostic
White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter
| Applicant | Cook Incorporated, Bloomington IN, US |
| Decision | Substantially Equivalent, May 26, 2017 |
| Received | Sep 1, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162448
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 1, 2026 | Cook Incorporated Aurous Centimeter Sizing Catheter
RPN N5.0-35-100-P-10S-PIG-CSC-20-01
GPN G47308
Sizing catheters are single-use, sterile catheters with gold marker bands. These catheters are for use in angiographic Open, Classified |
DQO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.