510(k) K001563 ยท FGO Dislodger, Stone, Flexible
SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET
| Applicant | Scion Cardiovascular, Inc., Miami FL, US |
| Decision | Substantially Equivalent, Nov 22, 2000 |
| Received | May 19, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001563
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 27, 2004 | Scion Cardio-Vascular, Inc. SCIPRO Flexible Stone Dislodger and Retrieval Set Catalog # SP3000146ST Terminated |
FGO | None listed |
| Feb 27, 2004 | Scion Cardio-Vascular, Inc. The device is SCIPRO Flexible Stone Dislodger and Retrieval Set, Catalog # SP3000146-ST used for removal of calculi, fragments of medical devices and other foreign objects uring urological or gatroent Terminated |
FGO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.