The following data is part of a premarket notification filed by Biosense Webster, Inc. with the FDA for Esophageal Mapping Catheter, Model D-1272-01-s.
| Device ID | K061463 |
| 510k Number | K061463 |
| Device Name: | ESOPHAGEAL MAPPING CATHETER, MODEL D-1272-01-S |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | BIOSENSE WEBSTER, INC. 3333 DIAMOND CANYON RD. Diamond Bar, CA 91765 |
| Contact | Natalie Bennington |
| Correspondent | Natalie Bennington 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 | 2006-05-26 |
| Decision Date | 2006-08-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10846835008227 | K061463 | 000 |