Cleared Traditional

Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter

K232130 · Surgical Instrument Services and Savings, Inc. · Cardiovascular
Dec 2023
Decision
151d
Days
Class 2
Risk

About This 510(k) Submission

K232130 is an FDA 510(k) clearance for the Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter, a Reprocessed Intravascular Ultrasound Catheter (Class II — Special Controls, product code OWQ), submitted by Surgical Instrument Services and Savings, Inc. (Redmond, US). The FDA issued a Cleared decision on December 15, 2023, 151 days after receiving the submission on July 17, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1200.

Submission Details

510(k) Number K232130 FDA.gov
FDA Decision Cleared SESE
Date Received July 17, 2023
Decision Date December 15, 2023
Days to Decision 151 days
Submission Type Traditional
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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