Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG)— 510(k) K250545
Substantially EquivalentSurgical Instrument Service and Savings, Inc.
FDA 510(k) clearance K250545 for Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG), Substantially Equivalent on 2025-06-05. Applicant: Surgical Instrument Service and Savings, Inc.. Device class: 2.
Clearance details
- Applicant
- Surgical Instrument Service and Savings, Inc.
- Product code
- Code OWQ
- Device class
- Class 2
- Regulation
- 21 CFR 870.1200
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Redmond, OR, US
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Recalls naming K250545
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K250545.
Data sourced from openFDA. This site is unofficial and independent of the FDA.