510(k) K000659 ยท DQO Catheter, Intravascular, Diagnostic
MODIFICATION TO SOFTOUCH DIAGNOSTIC INTRAVASCULAR CAT
| Applicant | Merit Medical Systems, Inc., Angleton TX, US |
| Decision | Substantially Equivalent, Mar 29, 2000 |
| Received | Feb 28, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K000659
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 28, 2010 | Merit Medical Systems, Inc. Vessel Sizing Angiographic Catheter, REF 7602-2M65, 5F PIG-VSC-2B, UHF Pigtail, Performa, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095.
Designed to be used for delivering radiopa Terminated |
DQO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.