Cleared Traditional

K162771 - EkoSonic Endovascular System with Contr...

K162771 is the FDA 510(k) clearance for EkoSonic Endovascular System with Contr... by Btg International, Inc.. It is a Class 2 Cardiovascular device (product code QEY) cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K162771 · Btg International, Inc. · Cardiovascular device
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Feb 2017
Decision
144d
Days
Class 2
Risk

K162771 is an FDA 510(k) clearance for the EkoSonic Endovascular System with Control Unit 4.0. 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 February 24, 2017 after a review of 144 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 K162771 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2016
Decision Date February 24, 2017
Days to Decision 144 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 125d · This submission: 144d
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 K162771.
Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200
K183290 · Thrombolex, Inc. · Feb 2019
EkoSonic Endovascular System
K182324 · Btg International, Inc. · Nov 2018
Pulse* Spray Infusion System, Uni*Fuse Infusion System
K163356 · AngioDynamics, Inc. · May 2017
SpeedLyser Infusion Catheter Kit
K170258 · AngioDynamics, Inc. · Feb 2017
Squirt Fluid Delivery System
K162777 · Merit Medical Systems, Inc. · Oct 2016
TRELLIS-8 PERIPHERAL INFUSION SYSTEM
K130904 · Covidien · Oct 2013