Cleared Traditional

K140151 - EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKO...

K140151 is the FDA 510(k) clearance for EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKO... by Btg International, Inc.. It is a Class 2 Cardiovascular device (product code QEY) cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K140151 · Btg International, Inc. · Cardiovascular device
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May 2014
Decision
119d
Days
Class 2
Risk

K140151 is an FDA 510(k) clearance for the EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT. Classified as Mechanical Thrombolysis Catheter (product code QEY), Class II - Special Controls.

Submitted by Btg International, Inc. (Bothell, US). The FDA issued a Cleared decision on May 21, 2014 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5150 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Btg International, Inc. devices

Submission Details

510(k) Number K140151 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2014
Decision Date May 21, 2014
Days to Decision 119 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 125d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QEY Mechanical Thrombolysis Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5150
Definition To Mechanically Disrupt Thrombus And/or Debris In The Peripheral Vasculature.
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 - QEY Mechanical Thrombolysis Catheter

All 30
Devices cleared under the same product code (QEY) and FDA review panel - the closest regulatory comparables to K140151.
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K992231 · Merit Medical Systems, Inc. · Jul 1999