510(k) K210655
K210655 is an FDA 510(k) premarket notification submitted by Innovative Health, LLC for the device "Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter". The FDA issued a decision of Substantially Equivalent on May 25, 2022. The device falls under product code OWQ (Reprocessed Intravascular Ultrasound Catheter), a Class II device regulated under 21 CFR 870.1200. Innovative Health, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 25, 2022
- Date Received
- March 4, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Reprocessed Intravascular Ultrasound Catheter
- Device Class
- Class II
- Regulation Number
- 870.1200
- Review Panel
- CV
- Submission Type
For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.