The following data is part of a premarket notification filed by Biosense Webster, Inc. with the FDA for Optrell Mapping Catheter With Trueref Technology.
| Device ID | K211438 |
| 510k Number | K211438 |
| Device Name: | OPTRELL Mapping Catheter With TRUEref Technology |
| Classification | Catheter, Intracardiac Mapping, High-density Array |
| Applicant | Biosense Webster, Inc. 31 Technology Drive Suite 200 Irvine, CA 92618 |
| Contact | John Jimenez |
| Correspondent | John Jimenez Biosense Webster, Inc. 31 Technology Drive Suite 200 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 | 2021-05-10 |
| Decision Date | 2022-03-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10846835023022 | K211438 | 000 |
| 10846835023015 | K211438 | 000 |