510(k) K192360
K192360 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "IntellaMap Orion High Resolution Mapping Catheter". The FDA issued a decision of Substantially Equivalent on Oct 25, 2019. The device falls under product code DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording), a Class II device regulated under 21 CFR 870.1220. Boston Scientific Corporation has 238 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 25, 2019
- Date Received
- Aug 30, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Electrode Recording, Or Probe, Electrode Recording
- Device Class
- Class II
- Regulation Number
- 870.1220
- Review Panel
- CV
- Submission Type
- 510(k)