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510(k) K182238

Reprocessed ViewFlex Xtra ICE Catheter by Stryker Sustainability Solutions — Product Code OWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 2019
Date Received
August 20, 2018
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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  • K232584 — Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocesse (October 24, 2023)
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