510(k) K203261
K203261 is an FDA 510(k) premarket notification submitted by Innovative Health, LLC for the device "Reprocessed Inquiry Steerable Diagnostic EP Catheter". The FDA issued a decision of Substantially Equivalent on March 5, 2021. The device falls under product code DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording), a Class II device regulated under 21 CFR 870.1220. Innovative Health, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 5, 2021
- Date Received
- November 5, 2020
- Clearance Type
- Special
- 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