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510(k) K230934

ViewFlex™ Eco Reprocessed ICE Catheter by Abbott Medical — Product Code OWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2023
Date Received
April 3, 2023
Clearance Type
Special
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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  • 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)
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