510(k) K142182
K142182 is an FDA 510(k) premarket notification submitted by Topera, Inc. for the device "FRIMAP ADAPTER CONNECTOR (MAC)". The FDA issued a decision of Substantially Equivalent on September 9, 2014. The device falls under product code MTD (Catheter, Intracardiac Mapping, High-Density Array), a Class II device regulated under 21 CFR 870.1220. Topera, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 9, 2014
- Date Received
- August 8, 2014
- Clearance Type
- Special
- 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