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510(k) K250545

Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG) by Surgical Instrument Service and Savings, Inc. — Product Code OWQ

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.

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Other clearances for product code OWQ

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  • K243101 — Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for S (March 10, 2025)
  • K234064 — Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Si (September 10, 2024)
  • K232130 — Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter (December 15, 2023)
  • K232584 — Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocesse (October 24, 2023)
  • K230928 — Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter (August 25, 2023)
  • K231621 — Reprocessed ViewFlex Xtra ICE Catheter (D087031) (July 25, 2023)
  • K231588 — ViewFlex™ Eco Reprocessed ICE Catheter (June 30, 2023)
  • K230584 — Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter (June 6, 2023)
  • K230934 — ViewFlex™ Eco Reprocessed ICE Catheter (May 3, 2023)