The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Constellation Multiple Electrode Recording & Pacing Catheter.
| Device ID | K140733 |
| 510k Number | K140733 |
| Device Name: | CONSTELLATION MULTIPLE ELECTRODE RECORDING & PACING CATHETER |
| Classification | Catheter, Intracardiac Mapping, High-density Array |
| Applicant | Boston Scientific Corporation 150 BAYTECH DRIVE San Jose, CA 95124 |
| Contact | Michelle Roeding |
| Correspondent | Michelle Roeding Boston Scientific Corporation 150 BAYTECH DRIVE San Jose, CA 95124 |
| Product Code | MTD |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-24 |
| Decision Date | 2014-04-28 |
| Summary: | summary |