Cleared Special

K042593 - ACUSON ACUNAV 8F ULTRASOUND CATHETER

K042593 is the FDA 510(k) clearance for ACUSON ACUNAV 8F ULTRASOUND 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 22-day FDA review.

K042593 · Siemens Medical Solutions USA, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2004
Decision
22d
Days
Class 2
Risk

K042593 is an FDA 510(k) clearance for the ACUSON ACUNAV 8F ULTRASOUND CATHETER. Classified as Catheter, Ultrasound, Intravascular (product code OBJ), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Mountain View, US). The FDA issued a Cleared decision on October 15, 2004 after a review of 22 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 K042593 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2004
Decision Date October 15, 2004
Days to Decision 22 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
103d faster than avg
Panel avg: 125d · This submission: 22d
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 K042593.
EAGLE EYE GOLD IVUS IMAGING CATHETER, MODEL 85900/859XX
K051337 · Volcano Corporation · Aug 2005
ILAB ULTRASOUND IMAGING SYSTEM
K051679 · Boston Scientific Corp · Jul 2005
REVOLUTION 45 MHZ ROTATIONAL IVUS IMAGING CATHETER
K050995 · Volcano Corporation · Jun 2005
MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456
K041727 · Boston Scientific Scimed, Inc. · Jul 2004
ACUNAV 90/10 DIAGNOSTIC ULTRASOUND CATHETER
K033650 · Siemens Medical Solutions USA, Inc. · Feb 2004