Cleared Traditional

K222217 - ViewFlex Xtra Reprocessed ICE Catheter

K222217 is the FDA 510(k) clearance for ViewFlex Xtra Reprocessed ICE Catheter by Abbott Medical. It is a Class 2 Cardiovascular device (product code OWQ) cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K222217 · Abbott Medical · Cardiovascular device
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Dec 2022
Decision
147d
Days
Class 2
Risk

K222217 is an FDA 510(k) clearance for the ViewFlex Xtra Reprocessed ICE Catheter. Classified as Reprocessed Intravascular Ultrasound Catheter (product code OWQ), Class II - Special Controls.

Submitted by Abbott Medical (Minnetonka, US). The FDA issued a Cleared decision on December 19, 2022 after a review of 147 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Abbott Medical devices

Submission Details

510(k) Number K222217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2022
Decision Date December 19, 2022
Days to Decision 147 days
Submission Type Traditional
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
22d slower than avg
Panel avg: 125d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OWQ Reprocessed Intravascular Ultrasound Catheter
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 - OWQ Reprocessed Intravascular Ultrasound Catheter

All 26
Devices cleared under the same product code (OWQ) and FDA review panel - the closest regulatory comparables to K222217.
Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter
K230584 · Vein 360, LLC · Jun 2023
ViewFlex™ Eco Reprocessed ICE Catheter
K230934 · Abbott Medical · May 2023
NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter
K223026 · Northeast Scientific, Inc. · Feb 2023
Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter
K210655 · Innovative Health, LLC · May 2022
Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter
K202042 · Innovative Health, LLC · Nov 2020
Reprocessed ViewFlex™ Xtra ICE Catheter
K190478 · Sterilmed, Inc. · Nov 2019