Cleared Traditional

K170992 - AcuNav V 10F Ultrasound Catheter

K170992 is the FDA 510(k) clearance for AcuNav V 10F Ultrasound Catheter by Siemens Medical Solutions USA, Inc.. It is a Class 2 Cardiovascular device (product code OBJ) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K170992 · Siemens Medical Solutions USA, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
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Jun 2017
Decision
73d
Days
Class 2
Risk

K170992 is an FDA 510(k) clearance for the AcuNav V 10F Ultrasound 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 June 15, 2017 after a review of 73 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Siemens Medical Solutions USA, Inc. devices

Submission Details

510(k) Number K170992 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2017
Decision Date June 15, 2017
Days to Decision 73 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
52d faster than avg
Panel avg: 125d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K170992.
ACUSON AcuNav Volume Intracardiac Echocardiography Catheter
K173618 · Siemens Medical Solutions USA, Inc. · Dec 2017
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K173284 · Boston Scientific Corporation · Nov 2017
AcuNav Diagnostic Ultrasound Catheter 8F,10F
K170263 · Siemens Medical Solutions USA, Inc. · Jun 2017
AcuNav Volume ICE Catheter
K163478 · Siemens Medical Solutions USA, Inc. · Feb 2017
REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip
K160583 · Volcano Corporation · Oct 2016
OptiCross 18, 30 MHz Peripheral Imaging Catheter
K160514 · Boston Scientific Corporation · Jun 2016