The following data is part of a premarket notification filed by Biosense Webster, Inc. with the FDA for Webster Duo-decapolar Catheter.
| Device ID | K101991 |
| 510k Number | K101991 |
| Device Name: | WEBSTER DUO-DECAPOLAR CATHETER |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | BIOSENSE WEBSTER, INC. 3333 DIAMOND CANYON RD. Diamond Bar, CA 91765 |
| Contact | Balaka Das |
| Correspondent | Balaka Das 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 | 2010-07-14 |
| Decision Date | 2011-05-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10846835017175 | K101991 | 000 |
| 10846835004960 | K101991 | 000 |