510(k) K000956 ยท DQO Catheter, Intravascular, Diagnostic
MODIFICATION TO SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATERS
| Applicant | Boston Scientific Scimed, Inc., Maple Grove MN, US |
| Decision | Substantially Equivalent, Apr 21, 2000 |
| Received | Mar 24, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K000956
| 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.