510(k) K020012 ยท DQO Catheter, Intravascular, Diagnostic
MODIFICATION TO RENEGADE FIBER BRAIDED MICROCATHETER
| Applicant | Boston Scientific/Medi-Tech, Natick, MA, US |
| Decision | Substantially Equivalent, Jan 29, 2002 |
| Received | Jan 3, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K020012
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 24, 2009 | Boston Scientific Corporation Boston Scientific, Renegade Fiber Braided Microcatheter, Peripheral Vascular Use, RX Only, Sterilized using ethylene oxide, Legal Manufacturer: Boston Scientific Cork Ltd., Business & Technology Park Terminated |
KRA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.