510(k) K250545
K250545 is an FDA 510(k) premarket notification submitted by Surgical Instrument Service and Savings, Inc. for the device "Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG)". The FDA issued a decision of Substantially Equivalent on June 5, 2025. The device falls under product code OWQ (Reprocessed Intravascular Ultrasound Catheter), a Class II device regulated under 21 CFR 870.1200. Surgical Instrument Service and Savings, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 5, 2025
- Date Received
- February 25, 2025
- 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.