Cleared Special

K191119 - EkoSonic Endovascular Device

K191119 is the FDA 510(k) clearance for EkoSonic Endovascular Device by Btg International, Inc.. It is a Class 2 Cardiovascular device (product code QEY) cleared through the Special 510(k) pathway after a 119-day FDA review.

K191119 · Btg International, Inc. · Cardiovascular device
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Aug 2019
Decision
119d
Days
Class 2
Risk

K191119 is an FDA 510(k) clearance for the EkoSonic Endovascular Device. 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 August 23, 2019 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. 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 Btg International, Inc. devices

Submission Details

510(k) Number K191119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2019
Decision Date August 23, 2019
Days to Decision 119 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
6d faster than avg
Panel avg: 125d · This submission: 119d
Pathway characteristics
Modification to existing cleared device.

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 29
Devices cleared under the same product code (QEY) and FDA review panel - the closest regulatory comparables to K191119.
UNI*FUSE Infusion System with Cooper Wire
K192864 · AngioDynamics, Inc. · Jun 2020
Bashir Plus Endovascular Catheter
K193071 · Thrombolex, Inc. · Dec 2019
Bashir S-B Endovascular Catheter, Ref. No. 7101
K192598 · Thrombolex, Inc. · Oct 2019
EkoSonic Endovascular Device with Control Unit 4.0
K183361 · Btg International, Inc. · Apr 2019
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