The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Intellamap Orion High Resolution Mapping Catheter.
| Device ID | K220796 |
| 510k Number | K220796 |
| Device Name: | IntellaMap Orion High Resolution Mapping Catheter |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | Boston Scientific Corporation 4100 Hamline Ave North St. Paul, MN 55112 |
| Contact | Melissa Schneider |
| Correspondent | Melissa Schneider Boston Scientific Corporation 4100 Hamline Ave North St. Paul, MN 55112 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-18 |
| Decision Date | 2022-06-10 |