Cleared Special

K191119 - EkoSonic Endovascular Device

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

K191119 · Btg International, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K191119

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.

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. 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 70
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
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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
K191119 · EkoSonic Endovascular Device
Download PDF FDA Summary Btg International, In…