510(k) K092425
K092425 is an FDA 510(k) premarket notification submitted by Ascent Healthcare Solutions for the device "REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETERS, MODEL SNDSTR10". The FDA issued a decision of Substantially Equivalent on October 21, 2009. The device falls under product code OWQ (Reprocessed Intravascular Ultrasound Catheter), a Class II device regulated under 21 CFR 870.1200. Ascent Healthcare Solutions has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 21, 2009
- Date Received
- August 7, 2009
- 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.