Cleared Special

K092064 - SOUNDSTAR 3D ULTRASOUND CATHETER

K092064 is the FDA 510(k) clearance for SOUNDSTAR 3D ULTRASOUND CATHETER by Biosense Webster, Inc.. It is a Class 2 Cardiovascular device (product code OBJ) cleared through the Special 510(k) pathway after a 30-day FDA review.

K092064 · Biosense Webster, Inc. · Cardiovascular device
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Aug 2009
Decision
30d
Days
Class 2
Risk

K092064 is an FDA 510(k) clearance for the SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-12. Classified as Catheter, Ultrasound, Intravascular (product code OBJ), Class II - Special Controls.

Submitted by Biosense Webster, Inc. (Diamond Bar, US). The FDA issued a Cleared decision on August 7, 2009 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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 Biosense Webster, Inc. devices

Submission Details

510(k) Number K092064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 2009
Decision Date August 07, 2009
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.

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 61
Devices cleared under the same product code (OBJ) and FDA review panel - the closest regulatory comparables to K092064.
SOUNDSTAR 3D ULTRASOUND CATHETER MODEL M-5723-12
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K073473 · Volcano Corporation · Jan 2008