510(k) K974559 ยท DQO Catheter, Intravascular, Diagnostic
SCIMED 6 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS
| Applicant | Scimed Life Systems, Inc., Maple Grove MN, US |
| Decision | Substantially Equivalent, Feb 23, 1998 |
| Received | Dec 5, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974559
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 31, 2008 | Boston Scientific Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen catheters with a single proximal hub for attachment to a dye delivery system. Catalog No. 16599-301. 6F MULT Terminated |
DQO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.