510(k) K964859 ยท DQO Catheter, Intravascular, Diagnostic
SCIMED 5 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS
| Applicant | Scimed Life Systems, Inc., Maple Grove MN, US |
| Decision | Substantially Equivalent, Feb 10, 1997 |
| Received | Dec 4, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964859
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 4, 2009 | Boston Scientific Corporation Boston Scientific Impulse Flextrusion Shaft, Angiographic Catheter, Sterilized with ethylene oxide gas, Made in Mexico, Parque Industrial La Mesa, Edificion G1, Suites B. H, Tijuana, Baja California 2 Terminated |
DQO | None listed |
| 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 |
| Aug 9, 2007 | Boston Scientific Corporation Boston Scientific Impulse Flextrusion Shaft 5F FR4 16391-02 H74916391022, (5-Pack Carton Label), Angiographic Catheters.
Made in Mexico Parque Industrial La Mesa Edificio G1, Suites B, H Tijuana, B Terminated |
DQO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.