510(k) K000825 ยท DQO Catheter, Intravascular, Diagnostic
4F-7F MEDI-DYNE TORQ FLOW XLB ANGIOGRAPHIC CATHETER
| Applicant | Medi-Dyne, Inc., Queensbury NY, US |
| Decision | Substantially Equivalent, Sep 21, 2000 |
| Received | Mar 14, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000825
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 28, 2003 | Jomed Catheters, Inc. JOGRAPHY Cardiovascular Angiographic Catheter, 5F *** pigtail *** tapered with perfusion ports *** MEDI-DYNE, INC., 604 Queensbury Ave., Queensbury, New York 12804 *** Single use, sterile, disposable Terminated |
None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.