The following data is part of a premarket notification filed by Biosense Webster, Inc. with the FDA for Lasso Nav Duo Loop Catheter.
| Device ID | K130602 |
| 510k Number | K130602 |
| Device Name: | LASSO NAV DUO LOOP CATHETER |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | BIOSENSE WEBSTER, INC. 3333 DIAMOND CANYON RD Diamond Bar, CA 91765 |
| Contact | John Jimenez |
| Correspondent | John Jimenez 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 | 2013-03-07 |
| Decision Date | 2013-08-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10846835012347 | K130602 | 000 |
| 10846835012316 | K130602 | 000 |
| 10846835013108 | K130602 | 000 |
| 10846835013092 | K130602 | 000 |
| 10846835012330 | K130602 | 000 |
| 10846835012323 | K130602 | 000 |