The following data is part of a premarket notification filed by Biosense Webster, Inc. with the FDA for Biosense Webster Lasso Deflectable Circular Mapping Catheter, Model D-1220.
| Device ID | K002333 |
| 510k Number | K002333 |
| Device Name: | BIOSENSE WEBSTER LASSO DEFLECTABLE CIRCULAR MAPPING CATHETER, MODEL D-1220 |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | BIOSENSE WEBSTER, INC. 3333 DIAMOND CANYON RD. Diamond Bar, CA 91765 |
| Contact | Maria D Ochoa |
| Correspondent | Maria D Ochoa BIOSENSE WEBSTER, INC. 3333 DIAMOND CANYON RD. Diamond Bar, CA 91765 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-01 |
| Decision Date | 2000-08-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10846835005882 | K002333 | 000 |
| 10846835000290 | K002333 | 000 |
| 10846835000313 | K002333 | 000 |
| 10846835000320 | K002333 | 000 |
| 10846835002300 | K002333 | 000 |
| 10846835002317 | K002333 | 000 |
| 10846835002324 | K002333 | 000 |
| 10846835005790 | K002333 | 000 |
| 10846835005806 | K002333 | 000 |
| 10846835005813 | K002333 | 000 |
| 10846835005820 | K002333 | 000 |
| 10846835005851 | K002333 | 000 |
| 10846835005868 | K002333 | 000 |
| 10846835005875 | K002333 | 000 |
| 10846835000283 | K002333 | 000 |