Cleared Traditional

K163560 - Reprocessed AcuNav Diagnostic Ultrasoun...

K163560 is the FDA 510(k) clearance for Reprocessed AcuNav Diagnostic Ultrasoun... by Innovative Health, LLC. It is a Class 2 Cardiovascular device (product code OWQ) cleared through the Traditional 510(k) pathway after a 205-day FDA review.

K163560 · Innovative Health, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2017
Decision
205d
Days
Class 2
Risk

K163560 is an FDA 510(k) clearance for the Reprocessed AcuNav 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 July 12, 2017 after a review of 205 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 Innovative Health, LLC devices

Submission Details

510(k) Number K163560 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2016
Decision Date July 12, 2017
Days to Decision 205 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
80d slower than avg
Panel avg: 125d · This submission: 205d
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 K163560.
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
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 Diagnostic Ultrasound Catheter
K153090 · Innovative Health, LLC · Mar 2016