510(k) K943739 ยท DQO Catheter, Intravascular, Diagnostic
SOFTOUCH DIAGNOSTIC INTRAVASCULAR CATHETER
| Applicant | Mallinckrodt Medical, St Louis MO, US |
| Decision | Substantially Equivalent, Nov 15, 1994 |
| Received | Aug 2, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K943739
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 22, 2013 | Merit Medical Systems, Inc. Merit Medical Performa Angiographic Catheter 5F Multipack. Part numbers 7560-43 and 7560-G3. Terminated |
DQO | None listed |
| May 25, 2013 | Merit Medical Systems, Inc. Merit Medical PerfOrma Anglographic Catheter 5F Multipack
Product Usage:
Angiographic catheters are designed to be used for delivering radiopaque media to selected sites in the vascular system in con Terminated |
DQO | None listed |
| Nov 27, 2003 | Merit Medical Systems, Inc UHF Cardiac Pigtail non-wirebraid, 7F, 110 cm, Angiographic Catheter, Sterile, Merit Medical. Terminated |
DQO | None listed |
| Nov 27, 2003 | Merit Medical Systems, Inc UHF Grollman Pigtail Long Tip Non-wirebraid, 7FG, 110 cm, Angiographic Catheter, Sterile, Merit Medical. Terminated |
DQO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.