K080425 is an FDA 510(k) clearance for the CS REFSTAR CATHETER (D- AND F-CURVES), MODELS D-1285-01 AND D-1285-02. This device is classified as a Catheter, Electrode Recording, Or Probe, Electrode Recording (Class II - Special Controls, product code DRF).
Submitted by Biosense Webster, Inc. (Diamond Bar, US). The FDA issued a Cleared decision on April 23, 2008, 68 days after receiving the submission on February 15, 2008.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1220.
| 510(k) Number | K080425 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 15, 2008 |
| Decision Date | April 23, 2008 |
| Days to Decision | 68 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 |