Cleared Special

ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System (K173063) - FDA 510(k) Clearance

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

K173063 · Acist Medical Systems, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Oct 2017
Decision
24d
Days
Class 2
Risk

K173063 is an FDA 510(k) clearance for the ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System. Classified as Catheter, Ultrasound, Intravascular (product code OBJ), Class II - Special Controls.

Submitted by Acist Medical Systems, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on October 23, 2017 after a review of 24 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Acist Medical Systems, Inc. devices

Submission Details

510(k) Number K173063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2017
Decision Date October 23, 2017
Days to Decision 24 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 125d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OBJ Catheter, Ultrasound, Intravascular
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 - OBJ Catheter, Ultrasound, Intravascular

All 43
Devices cleared under the same product code (OBJ) and FDA review panel - the closest regulatory comparables to K173063.
OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU), OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (e-DFU)
K173820 · Boston Scientific Corporation · Jan 2018
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K173618 · Siemens Medical Solutions USA, Inc. · Dec 2017
OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU)
K173284 · Boston Scientific Corporation · Nov 2017
AcuNav Diagnostic Ultrasound Catheter 8F,10F
K170263 · Siemens Medical Solutions USA, Inc. · Jun 2017
AcuNav V 10F Ultrasound Catheter
K170992 · Siemens Medical Solutions USA, Inc. · Jun 2017
AcuNav Volume ICE Catheter
K163478 · Siemens Medical Solutions USA, Inc. · Feb 2017