Cleared Traditional

Reprocessed ViewFlex™ Xtra ICE Catheter (K190478) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K190478 · Sterilmed, Inc. · Cardiovascular device
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Nov 2019
Decision
260d
Days
Class 2
Risk

K190478 is an FDA 510(k) clearance for the Reprocessed ViewFlex™ Xtra ICE Catheter. Classified as Reprocessed Intravascular Ultrasound Catheter (product code OWQ), Class II - Special Controls.

Submitted by Sterilmed, Inc. (Plymouth, US). The FDA issued a Cleared decision on November 14, 2019 after a review of 260 days - an extended review cycle.

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 Sterilmed, Inc. devices

Submission Details

510(k) Number K190478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2019
Decision Date November 14, 2019
Days to Decision 260 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
135d slower than avg
Panel avg: 125d · This submission: 260d
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 18
Devices cleared under the same product code (OWQ) and FDA review panel - the closest regulatory comparables to K190478.
ViewFlex Xtra Reprocessed ICE Catheter
K222217 · Abbott Medical · Dec 2022
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
K182238 · Stryker Sustainability Solutions · May 2019
Reprocessed Visions PV .035 Digital IVUS Catheter
K181126 · Innovative Health, LLC · Jan 2019
Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter
K173262 · Innovative Health, LLC · Mar 2018