K895916 is an FDA 510(k) clearance for the PE INTERCARDIAC MAPPING SYSTEM (ICMS). This device is classified as a Catheter, Electrode Recording, Or Probe, Electrode Recording (Class II - Special Controls, product code DRF).
Submitted by Prucka Engineering, Inc. (Bellaire, US). The FDA issued a Cleared decision on December 13, 1989, 64 days after receiving the submission on October 10, 1989.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1220.
| 510(k) Number | K895916 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 10, 1989 |
| Decision Date | December 13, 1989 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DRF — Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1220 |