Cleared Traditional

K140151 - EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT

K140151 is an FDA 510(k) clearance for EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKO..., manufactured by Btg International, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K140151

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 125d · This submission: 119d
Pathway characteristics
Predicate-based equivalence.

QEY Device Classification - Class 2, Special Controls

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01166997 Completed Interventional Industry-sponsored

ULTrasound Accelerated ThrombolysIs of PulMonAry Embolism

Randomized, Controlled Study Comparing EKOS EkoSonic Ultrasound Accelerated Thrombolysis to Anticoagulation in the Treatment of Sub-massive Pulmonary Embolism

59
Patients (actual)
10
Sites
Treatment
Purpose
Single blind
Masking
Condition studied Submassive Pulmonary Embolism
Study design Parallel
Eligibility All sexes · 18 Years+
Principal investigator Nils Kucher, Prof Dr med
Sponsor Boston Scientific Corporation (industry)
Started 2010-07-01 → Primary completion 2013-04-01 → Completed 2013-05-01
Primary outcome
Reduction of RV/LV Ratio
View full study on ClinicalTrials.gov

Regulatory Peers - QEY Mechanical Thrombolysis Catheter

All 57
Devices cleared under the same product code (QEY) and FDA review panel - the closest regulatory comparables to K140151.
Squirt Fluid Delivery System
K162777 · Merit Medical Systems, Inc. · Oct 2016
Occlusion Perfusion Catheter
K153488 · Advanced Catheter Therapies, Inc. · Feb 2016
Occlusion Perfusion Catheter
K151554 · Advanced Catheter Therapies, Inc. · Sep 2015
TRELLIS-8 PERIPHERAL INFUSION SYSTEM
K130904 · Covidien · Oct 2013
EKOSONIC ENDOVASCULAR SYSTEM
K111705 · Ekos Corporation · Aug 2011
EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATION
K081467 · Ekos Corp. · Jun 2008