510(k) K924163 ยท DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
EXPLORER/360-POLARIS-L.E./JACKMAN CORON SINUS ELEC
| Applicant | Boston Scientific Corp, San Jose CA, US |
| Decision | Substantially Equivalent, Sep 3, 1993 |
| Received | Aug 19, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K924163
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 22, 2007 | Boston Scientific Corp Polaris Dx Diagnostic Catheter, for cardiac electrophysiology studies, Model M0049663S0 Terminated |
DRF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.