510(k) K161801 ยท KRA Catheter, Continuous Flush
CrossCath Support Catheter
| Applicant | Cook Incorporated, Bloomington IN, US |
| Decision | Substantially Equivalent, Jul 29, 2016 |
| Received | Jun 30, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K161801
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 9, 2019 | Cook Inc. CrossCath Support Catheter, RPN CXC3.0-1.9-14-90-P-NS-0, Order Number G51572 For diagnostic and interventional vascular procedures. Terminated |
KRA | None listed |
| Dec 9, 2019 | Cook Inc. CrossCath Support Catheter, RPN CXC3.4-2.2-18-90-P-NS-0, Order Number G51575 For diagnostic and interventional vascular procedures. Terminated |
KRA | None listed |
| Dec 9, 2019 | Cook Inc. CrossCath Support Catheter, RPN CXC3.4-2.2-18-135-P-NS-0, Order Number G51583 For diagnostic and interventional vascular procedures. Terminated |
KRA | None listed |
| Dec 9, 2019 | Cook Inc. CrossCath Support Catheter, RPN CXC3.4-2.2-18-150-P-NS-0, Order Number G51577 For diagnostic and interventional vascular procedures. Terminated |
KRA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.