Submission Details
| 510(k) Number | K250545 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 25, 2025 |
| Decision Date | June 05, 2025 |
| Days to Decision | 100 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG)
Jun 2025
Decision
100d
Days
Class 2
Risk
About This 510(k) Submission
K250545 is an FDA 510(k) clearance for the Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG), a Reprocessed Intravascular Ultrasound Catheter (Class II — Special Controls, product code OWQ), submitted by Surgical Instrument Service and Savings, Inc. (Redmond, US). The FDA issued a Cleared decision on June 5, 2025, 100 days after receiving the submission on February 25, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1200.
Device Classification
| Product Code | OWQ — Reprocessed Intravascular Ultrasound Catheter |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1200 |
| Definition | For Intracardiac And Intraluminal Visualization Of Cardiovascular Anatomy And Physiology. |
Manufacturer
Surgical Instrument Service and Savings, Inc.
Redmond, OR · US
Stephanie Boyle Mays
23 submissions
23 cleared
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