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510(k) K231621

Reprocessed ViewFlex Xtra ICE Catheter (D087031) by Stryker Sustainability Solutions — Product Code OWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2023
Date Received
June 2, 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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Other clearances for product code OWQ

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  • K232584 — Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocesse (October 24, 2023)
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