Cleared Special

K202042 - Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter

K202042 is an FDA 510(k) clearance for Reprocessed ViewFlex Xtra Ice Diagnosti..., manufactured by Innovative Health, LLC. The device is a Class 2 Cardiovascular device with product code OWQ cleared through the Special 510(k) pathway after a 120-day FDA review.

K202042 · Innovative Health, LLC · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2020
Decision
120d
Days
Class 2
Risk

K202042 is an FDA 510(k) clearance for the Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter. Classified as Reprocessed Intravascular Ultrasound Catheter (product code OWQ), Class II - Special Controls.

Submitted by Innovative Health, LLC (Scottsdale, US). The FDA issued a Cleared decision on November 20, 2020 after a review of 120 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K202042

510(k) Number K202042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2020
Decision Date November 20, 2020
Days to Decision 120 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
5d faster than avg
Panel avg: 125d · This submission: 120d
Pathway characteristics
Modification to existing cleared device.

OWQ Device Classification - Class 2, Special Controls

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 29
Devices cleared under the same product code (OWQ) and FDA review panel - the closest regulatory comparables to K202042.
NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter
K223026 · Northeast Scientific, Inc. · Feb 2023
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 Catheter
K190478 · Sterilmed, Inc. · Nov 2019
Reprocessed ViewFlex Xtra ICE Catheter
K182238 · Stryker Sustainability Solutions · May 2019
Reprocessed Visions PV .035 Digital IVUS Catheter
K181126 · Innovative Health, LLC · Jan 2019
K202042 · Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter
Download PDF FDA Summary Innovative Health, LLC