510(k) K101659 ยท DQY Catheter, Percutaneous
SUPERCROSS MICROCATHETER (130 CM), SUPERCROSS MICROCATHETER (150 CM) MODEL 5300, 5301
| Applicant | Vascular Solutions, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Dec 16, 2010 |
| Received | Jun 11, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101659
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 20, 2013 | Vascular Solutions, Inc. Vascular Solutions, SuperCross Microcatheter, Sterilized using ethylene oxide, Rx Only, Model numbers 5300 - 5307, 5324, 5325, 5329, 5332, 5336, 5340, and 5341.
Product Usage:
The SuperCross catheter Terminated |
DQY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.