The following data is part of a premarket notification filed by Biosense Webster, Inc. with the FDA for Flower High-density Mapping Catheter, 4-4-4 Mm Electrode Spacing), (2-6-2 Mm Electrode Spacing).
| Device ID | K050217 |
| 510k Number | K050217 |
| Device Name: | FLOWER HIGH-DENSITY MAPPING CATHETER, 4-4-4 MM ELECTRODE SPACING), (2-6-2 MM ELECTRODE SPACING) |
| Classification | Catheter, Intracardiac Mapping, High-density Array |
| Applicant | BIOSENSE WEBSTER, INC. 3333 DIAMOND CANYON RD. Diamond Bar, CA 91765 |
| Contact | Wayne R Hohman |
| Correspondent | Wayne R Hohman BIOSENSE WEBSTER, INC. 3333 DIAMOND CANYON RD. Diamond Bar, CA 91765 |
| Product Code | MTD |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-31 |
| Decision Date | 2005-03-30 |
| Summary: | summary |