Cleared Special

Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter (K202042) - FDA 510(k) Clearance

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

K202042 · Innovative Health, LLC · Cardiovascular device
Download Printable Device Report (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.

View all Innovative Health, LLC devices

Submission Details

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.

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 29
Devices cleared under the same product code (OWQ) and FDA review panel - the closest regulatory comparables to K202042.
Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG)
K250545 · Surgical Instrument Service and Savings, Inc. · Jun 2025
NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700)
K250592 · Northeast Scientific, Inc. · May 2025
Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 )
K243101 · Surgical Instrument Service and Savings, Inc. · Mar 2025
Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Siemens Systems) (10135936)
K234064 · Surgical Instrument Service and Savings, Inc. · Sep 2024
Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter
K232130 · Surgical Instrument Services and Savings, Inc. · Dec 2023
Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter
K232584 · Vein 360, LLC · Oct 2023