K924163 is an FDA 510(k) clearance for the EXPLORER/360-POLARIS-L.E./JACKMAN CORON SINUS ELEC. This device is classified as a Catheter, Electrode Recording, Or Probe, Electrode Recording (Class II - Special Controls, product code DRF).
Submitted by Boston Scientific Corp (San Jose, US). The FDA issued a Cleared decision on September 3, 1993, 380 days after receiving the submission on August 19, 1992.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1220.
| 510(k) Number | K924163 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 19, 1992 |
| Decision Date | September 03, 1993 |
| Days to Decision | 380 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DRF — Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1220 |