The following data is part of a premarket notification filed by Boston Scienfitic Corporation with the FDA for Intellamap Orion High Resolution Mapping Catheter.
| Device ID | K192360 |
| 510k Number | K192360 |
| Device Name: | IntellaMap Orion High Resolution Mapping Catheter |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | Boston Scienfitic Corporation 4100 Hamline Ave North St.paul, MN 55112 |
| Contact | Nicole Lyden |
| Correspondent | Nicole Lyden Boston Scienfitic Corporation 4100 Hamline Ave North St.paul, MN 55112 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-30 |
| Decision Date | 2019-10-25 |
| Summary: | summary |