The following data is part of a premarket notification filed by Biosense Webster, Inc. with the FDA for Lassostar Nav Circular Mapping Catheter.
| Device ID | K211219 |
| 510k Number | K211219 |
| Device Name: | LASSOSTAR NAV Circular Mapping Catheter |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | Biosense Webster, Inc. 31 Technology Drive Suite 200 Irvine, CA 92618 |
| Contact | Michelle Wheeler |
| Correspondent | Michelle Wheeler Biosense Webster, Inc. 31 Technology Drive Suite 200 Irvine, CA 92618 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-23 |
| Decision Date | 2022-01-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10846835020359 | K211219 | 000 |
| 10846835020342 | K211219 | 000 |
| 10846835020335 | K211219 | 000 |