510(k) K060327 ยท DQY Catheter, Percutaneous
VASCULAR SOLUTIONS TWIN-PASS DUAL ACCESS CATHETER AND SKYWAY SUPPORT CATHETER
| Applicant | Vascular Solutions, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Apr 12, 2006 |
| Received | Feb 9, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060327
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 20, 2016 | Vascular Solutions, Inc. Vascular Solutions Twin-Pass RX Dual Access Catheter, model 5210. Sterilized with Ethylene Oxide.
The Twin-Pass dual access catheter is a dual lumen catheter designed for use in the coronary and/or Terminated |
DQY | None listed |
| Aug 21, 2009 | Vascular Solutions, Inc. Twin-Pass Dual Access Catheter , REF 5200, sterilized with Ethylene Oxide, RX Only, Non-Pyrogenic, Manufactured by Vascular Solutions, Inc., 6464 Sycamore Court, Minneapolis, MN 55369.
The TWIN-PASS Terminated |
DQY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.