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510(k) K232584

Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter by Vein 360, LLC — Product Code OWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 2023
Date Received
August 25, 2023
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 Vein 360, LLC

  • K230928 — Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter (August 25, 2023)
  • K230584 — Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter (June 6, 2023)
  • K191073 — Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter (October 22, 2019)

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)
  • 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)
  • 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)