The following data is part of a premarket notification filed by Biosense Webster, Inc with the FDA for Pentaray Nav Eco High-density Mapping Catheter.
| Device ID | K201750 |
| 510k Number | K201750 |
| Device Name: | Pentaray Nav Eco High-Density Mapping Catheter |
| Classification | Catheter, Intracardiac Mapping, High-density Array |
| Applicant | Biosense Webster, Inc 33 Technology Dr Irvine, CA 92618 |
| Contact | Richard Lauhead |
| Correspondent | Richard Lauhead Biosense Webster, Inc 33 Technology Dr Irvine, CA 92618 |
| Product Code | MTD |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-26 |
| Decision Date | 2020-08-06 |