Cleared Special

K163478 - AcuNav Volume ICE Catheter

K163478 is the FDA 510(k) clearance for AcuNav Volume ICE Catheter by Siemens Medical Solutions USA, Inc.. It is a Class 2 Cardiovascular device (product code OBJ) cleared through the Special 510(k) pathway after a 59-day FDA review.

K163478 · Siemens Medical Solutions USA, Inc. · Cardiovascular device
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Feb 2017
Decision
59d
Days
Class 2
Risk

K163478 is an FDA 510(k) clearance for the AcuNav Volume ICE Catheter. Classified as Catheter, Ultrasound, Intravascular (product code OBJ), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Moutain View, US). The FDA issued a Cleared decision on February 9, 2017 after a review of 59 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 Siemens Medical Solutions USA, Inc. devices

Submission Details

510(k) Number K163478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2016
Decision Date February 09, 2017
Days to Decision 59 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
66d faster than avg
Panel avg: 125d · This submission: 59d
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 62
Devices cleared under the same product code (OBJ) and FDA review panel - the closest regulatory comparables to K163478.
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