The following data is part of a premarket notification filed by Biosense Webster, Inc. with the FDA for Variable Lasso 2515 Circular Mapping Catheter.
| Device ID | K031161 |
| 510k Number | K031161 |
| Device Name: | VARIABLE LASSO 2515 CIRCULAR MAPPING CATHETER |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | BIOSENSE WEBSTER, INC. 3333 DIAMOND CANYON RD. Diamond Bar, CA 91765 |
| Contact | William Welch |
| Correspondent | William Welch 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 | 2003-04-14 |
| Decision Date | 2003-07-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10846835002348 | K031161 | 000 |
| 10846835000337 | K031161 | 000 |
| 10846835000306 | K031161 | 000 |