The following data is part of a premarket notification filed by Biosense Webster, Inc. with the FDA for Refstar Plus With Qwikpatch External Reference Patch, Model D-1210-03, Refstar Plus Cable, Model M-4700-106.
| Device ID | K090120 |
| 510k Number | K090120 |
| Device Name: | REFSTAR PLUS WITH QWIKPATCH EXTERNAL REFERENCE PATCH, MODEL D-1210-03, REFSTAR PLUS CABLE, MODEL M-4700-106 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-21 |
| Decision Date | 2009-03-24 |
| Summary: | summary |