Cleared Special

ViewFlex? X ICE Catheter, Sensor Enabled?

K251231 · Abbott Medical · Cardiovascular
May 2025
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K251231 is an FDA 510(k) clearance for the ViewFlex? X ICE Catheter, Sensor Enabled?, a Catheter, Ultrasound, Intravascular (Class II — Special Controls, product code OBJ), submitted by Abbott Medical (Irvine, US). The FDA issued a Cleared decision on May 20, 2025, 28 days after receiving the submission on April 22, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1200.

Submission Details

510(k) Number K251231 FDA.gov
FDA Decision Cleared SESE
Date Received April 22, 2025
Decision Date May 20, 2025
Days to Decision 28 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code OBJ — Catheter, Ultrasound, Intravascular
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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