510(k) K872090 ยท DQT Occluder, Catheter Tip
THE ROBICSEK - PRUITT AORTIC BALLOON OCCLUSION KIT
| Applicant | Ideas For Medicine, Inc., Clearwater FL, US |
| Decision | Substantially Equivalent, Oct 30, 1987 |
| Received | Jun 1, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K872090
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 30, 2005 | LeMaitre Vascular, Inc. Product is a Pruitt Aortic Occlusion Catheter contained in a molded tray. The product is labeled in part: ''***LeMaitre VASCULAR***Distributed By:LeMaitre Vascular, Inc.***Manufactured By: LeMaitre Terminated |
DQT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.