Cleared Traditional

K153090 - Reprocessed Diagnostic Ultrasound Catheter

K153090 is an FDA 510(k) clearance for Reprocessed Diagnostic Ultrasound Catheter, manufactured by Innovative Health, LLC. The device is a Class 2 Cardiovascular device with product code OWQ cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K153090 · Innovative Health, LLC · Cardiovascular device
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Mar 2016
Decision
136d
Days
Class 2
Risk

K153090 is an FDA 510(k) clearance for the Reprocessed 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 March 10, 2016 after a review of 136 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 Innovative Health, LLC devices

FDA 510(k) Submission Details - K153090

510(k) Number K153090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2015
Decision Date March 10, 2016
Days to Decision 136 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
11d slower than avg
Panel avg: 125d · This submission: 136d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K153090.
Reprocessed AcuNav Diagnostic Ultrasound Catheter
K163560 · Innovative Health, LLC · Jul 2017
Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter
K170474 · Innovative Health, LLC · Jun 2017
SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound Catheters
K161700 · Sterilmed, Inc. · Nov 2016
REPROCESSED ULTRASOUND INTRACARDIAC ECHO CATHETER
K121913 · Stryker Sustainability Solutions, Inc. · Dec 2012
REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETER
K110076 · Sterilmed, Inc. · Aug 2011
REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETERS, MODEL SNDSTR10
K092425 · Ascent Healthcare Solutions · Oct 2009