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510(k) K243101

Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 ); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for GE Systems) (10043342) by Surgical Instrument Service and Savings, Inc. — Product Code OWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 2025
Date Received
September 30, 2024
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.

Other clearances by Surgical Instrument Service and Savings, Inc.

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  • K250772 — Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerabl (July 11, 2025)
  • K250545 — Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound (June 5, 2025)
  • K242225 — Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter (November 29, 2024)
  • K241156 — Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter (September 14, 2024)
  • K234064 — Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Si (September 10, 2024)
  • K240972 — Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC) (June 7, 2024)
  • K232511 — Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019) (April 29, 2024)
  • K221067 — Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiolog (May 31, 2023)

Other clearances for product code OWQ

  • K250545 — Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound (June 5, 2025)
  • K250592 — NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700) (May 12, 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)