The following data is part of a premarket notification filed by Biosense Webster, Inc. with the FDA for Coronary Sinus Deflectable Mapping Catheter, 4 Fr, 5 Fr, 6 Fr & 7 Fr.
| Device ID | K050877 |
| 510k Number | K050877 |
| Device Name: | CORONARY SINUS DEFLECTABLE MAPPING CATHETER, 4 FR, 5 FR, 6 FR & 7 FR |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | BIOSENSE WEBSTER, INC. 3333 DIAMOND CANYON RD. Diamond Bar, CA 91765 |
| Contact | Michael Johnson |
| Correspondent | Michael Johnson 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 | 2005-04-06 |
| Decision Date | 2005-06-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10846835004182 | K050877 | 000 |
| 10846835004175 | K050877 | 000 |
| 10846835004120 | K050877 | 000 |
| 10846835004113 | K050877 | 000 |
| 10846835004106 | K050877 | 000 |
| 10846835003994 | K050877 | 000 |
| 10846835003987 | K050877 | 000 |