Cleared Special

Reprocessed ViewFlex Xtra ICE Catheter (D087031)

K231621 · Stryker Sustainability Solutions · Cardiovascular
Jul 2023
Decision
53d
Days
Class 2
Risk

About This 510(k) Submission

K231621 is an FDA 510(k) clearance for the Reprocessed ViewFlex Xtra ICE Catheter (D087031), a Reprocessed Intravascular Ultrasound Catheter (Class II — Special Controls, product code OWQ), submitted by Stryker Sustainability Solutions (Tempe, US). The FDA issued a Cleared decision on July 25, 2023, 53 days after receiving the submission on June 2, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1200.

Submission Details

510(k) Number K231621 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 2023
Decision Date July 25, 2023
Days to Decision 53 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code OWQ — Reprocessed Intravascular Ultrasound Catheter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1200
Definition For Intracardiac And Intraluminal Visualization Of Cardiovascular Anatomy And Physiology.

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