Cleared Special

K160173 - Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)

K160173 is an FDA 510(k) clearance for Ultra ICE Plus 9 MHz IntraCardiac Echo ..., manufactured by Boston Scientific Corporation. The device is a Class 2 Cardiovascular device with product code DXK cleared through the Special 510(k) pathway after a 30-day FDA review.

K160173 · Boston Scientific Corporation · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2016
Decision
30d
Days
Class 2
Risk

K160173 is an FDA 510(k) clearance for the Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz I.... Classified as Echocardiograph (product code DXK), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Fremont, US). The FDA issued a Cleared decision on February 26, 2016 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2330 - 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.

FDA 510(k) Submission Details - K160173

510(k) Number K160173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2016
Decision Date February 26, 2016
Days to Decision 30 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
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

DXK Device Classification - Class 2, Special Controls

Product Code DXK Echocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2330
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 - DXK Echocardiograph

All 77
Devices cleared under the same product code (DXK) and FDA review panel - the closest regulatory comparables to K160173.
Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter
K181042 · Boston Scientific Corporation · May 2018
IN-VISION IMAGING SYSTEM
K031148 · Jomed, Inc. · May 2003
9750 ATHENA ETHERNET OPTION
K934887 · S & W Medico Teknik A/S · Jan 1994
ACCESSORY TO GENESIS III (GCFM)
K913209 · Biosound, Inc. · May 1992
CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600
K911384 · Endosonics Corp. · Jun 1991
MODIFIED SYST: SONOS 500/1000 ULTRSOUND IMAG SYST
K904832 · Hewlett-Packard Co. · Apr 1991
K160173 · Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)
Download PDF FDA Summary Boston Scientific Cor…