The following data is part of a premarket notification filed by Biosense Webster, Inc. with the FDA for Variable Lasso Nav Catheter, Models: D-1290-01, D-1290-02.
| Device ID | K081258 |
| 510k Number | K081258 |
| Device Name: | VARIABLE LASSO NAV CATHETER, MODELS: D-1290-01, D-1290-02 |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | BIOSENSE WEBSTER, INC. 3333 DIAMOND CANYON RD. Diamond Bar, CA 91765 |
| Contact | Natalie Bennington |
| Correspondent | Natalie Bennington BIOSENSE WEBSTER, INC. 3333 DIAMOND CANYON RD. Diamond Bar, CA 91765 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-02 |
| Decision Date | 2009-01-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10846835008296 | K081258 | 000 |
| 10846835008272 | K081258 | 000 |