The following data is part of a premarket notification filed by Biosense Webster, Inc. with the FDA for Carto Octaray Mapping Catheter With Trueref Technology.
| Device ID | K193237 |
| 510k Number | K193237 |
| Device Name: | Carto Octaray Mapping Catheter With Trueref Technology |
| 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 | 2019-11-25 |
| Decision Date | 2020-07-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10846835022056 | K193237 | 000 |
| 10846835021233 | K193237 | 000 |
| 10846835021158 | K193237 | 000 |
| 10846835021141 | K193237 | 000 |
| 10846835021134 | K193237 | 000 |
| 10846835021127 | K193237 | 000 |
| 10846835021110 | K193237 | 000 |