K953750 is an FDA 510(k) clearance for the CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING. 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 (Natick,, US). The FDA issued a Cleared decision on March 11, 1996, 214 days after receiving the submission on August 10, 1995.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1220.
| 510(k) Number | K953750 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 10, 1995 |
| Decision Date | March 11, 1996 |
| Days to Decision | 214 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 |