K081258 is an FDA 510(k) clearance for the VARIABLE LASSO NAV CATHETER, MODELS: D-1290-01, D-1290-02. 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 January 6, 2009, 249 days after receiving the submission on May 2, 2008.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1220.
| 510(k) Number | K081258 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 02, 2008 |
| Decision Date | January 06, 2009 |
| Days to Decision | 249 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 |