510(k) K170474
K170474 is an FDA 510(k) premarket notification submitted by Innovative Health, LLC for the device "Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter". The FDA issued a decision of Substantially Equivalent on Jun 16, 2017. 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 49 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 16, 2017
- Date Received
- Feb 16, 2017
- 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
- 510(k)
For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.