510(k) K210313
K210313 is an FDA 510(k) premarket notification submitted by Shanghai Microport EP Medtech Co., Ltd. for the device "EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter". The FDA issued a decision of Substantially Equivalent on December 30, 2022. The device falls under product code DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording), a Class II device regulated under 21 CFR 870.1220. Shanghai Microport EP Medtech Co., Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 30, 2022
- Date Received
- February 3, 2021
- 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