510(k) K193237
K193237 is an FDA 510(k) premarket notification submitted by Biosense Webster, Inc. for the device "Carto Octaray Mapping Catheter with Trueref Technology". The FDA issued a decision of Substantially Equivalent on July 31, 2020. The device falls under product code MTD (Catheter, Intracardiac Mapping, High-Density Array), a Class II device regulated under 21 CFR 870.1220. Biosense Webster, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 31, 2020
- Date Received
- November 25, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Intracardiac Mapping, High-Density Array
- Device Class
- Class II
- Regulation Number
- 870.1220
- Review Panel
- CV
- Submission Type