The following data is part of a premarket notification filed by Biosense Webster, Inc. with the FDA for Lasso Nav Catheter.
| Device ID | K093376 |
| 510k Number | K093376 |
| Device Name: | LASSO NAV CATHETER |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | BIOSENSE WEBSTER, INC. 3333 DIAMOND CANYON RD. Diamond Bar, CA 91765 |
| Contact | Wayne Hohman |
| Correspondent | Wayne Hohman 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 | 2009-10-29 |
| Decision Date | 2010-06-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10846835006780 | K093376 | 000 |
| 10846835006827 | K093376 | 000 |
| 10846835006797 | K093376 | 000 |
| 10846835009446 | K093376 | 000 |
| 10846835006834 | K093376 | 000 |
| 10846835006810 | K093376 | 000 |
| 10846835006803 | K093376 | 000 |