Cleared Special

K112050 - SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER

K112050 is an FDA 510(k) clearance for SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CAT..., manufactured by Biosense Webster, Inc.. The device is a Class 2 Cardiovascular device with product code OBJ cleared through the Special 510(k) pathway after a 123-day FDA review.

K112050 · Biosense Webster, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2011
Decision
123d
Days
Class 2
Risk

K112050 is an FDA 510(k) clearance for the SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER. 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 November 18, 2011 after a review of 123 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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

FDA 510(k) Submission Details - K112050

510(k) Number K112050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2011
Decision Date November 18, 2011
Days to Decision 123 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
2d faster than avg
Panel avg: 125d · This submission: 123d
Pathway characteristics
Modification to existing cleared device.

OBJ Device Classification - Class 2, Special Controls

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 73
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