Cleared Special

ViewFlex Xtra ICE Catheter (K223077) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K223077 · Irvine Biomedical, A St. Jude Medical Company · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2022
Decision
68d
Days
Class 2
Risk

K223077 is an FDA 510(k) clearance for the ViewFlex Xtra ICE Catheter. Classified as Catheter, Ultrasound, Intravascular (product code OBJ), Class II - Special Controls.

Submitted by Irvine Biomedical, A St. Jude Medical Company (Irvine, US). The FDA issued a Cleared decision on December 7, 2022 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Irvine Biomedical, A St. Jude Medical Company devices

Submission Details

510(k) Number K223077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2022
Decision Date December 07, 2022
Days to Decision 68 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 125d · This submission: 68d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OBJ Catheter, Ultrasound, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
Definition For Intracardiac And Intraluminal Visualization Of Cardiovascular Anatomy And Physiology.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - OBJ Catheter, Ultrasound, Intravascular

All 42
Devices cleared under the same product code (OBJ) and FDA review panel - the closest regulatory comparables to K223077.
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