510(k) K112554 ยท DYB Introducer, Catheter
TRANSRADIAL ARTERY ACCESS DEVICES
| Applicant | Teleflexmedical, Inc., Reading PA, US |
| Decision | Substantially Equivalent, Nov 18, 2011 |
| Received | Sep 2, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112554
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 9, 2013 | Arrow International Inc Arrow Transradial Artery Access products
Arrow Transradial Artery Access products are used for percutaneous introduction of devices into the radial artery for diagnostic and therapeutic purposes. Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.