The following data is part of a premarket notification filed by Biosense Webster, Inc. with the FDA for Webster Cs Catheter With Ez Steer Technology, Webster Cs Catheter With Ez Steer Technology And Auto Id Model: D-1263-04,.
| Device ID | K101345 |
| 510k Number | K101345 |
| Device Name: | WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY, WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY AND AUTO ID MODEL: D-1263-04, |
| 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 | 2010-05-13 |
| Decision Date | 2010-06-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10846835002430 | K101345 | 000 |
| 10846835002423 | K101345 | 000 |
| 10846835002416 | K101345 | 000 |
| 10846835002409 | K101345 | 000 |