510(k) K040569 ยท DTB Permanent Pacemaker Electrode
PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU
| Applicant | Oscor, Inc., Palm Harbor FL, US |
| Decision | Substantially Equivalent, Apr 7, 2004 |
| Received | Mar 4, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K040569
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 24, 2008 | Oscor, Inc. Permanent Pacing Lead (Catalog #: 03332, 03334, 03337, 03107, 03116, 03108, 03109, 05756, 53420, 05765, 03634, 03633, and 05747); Model #: PY244RU, PY252RU, PY258RU, REFINO58RU, REFINO 52RJU, REFINO 4 Terminated |
DTB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.