Cleared Traditional

K183361 - EkoSonic Endovascular Device with Control Unit 4.0

K183361 is an FDA 510(k) clearance for EkoSonic Endovascular Device with Contr..., 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 122-day FDA review.

K183361 · Btg International, Inc. · Cardiovascular device
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Apr 2019
Decision
122d
Days
Class 2
Risk

K183361 is an FDA 510(k) clearance for the EkoSonic Endovascular Device 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 April 5, 2019 after a review of 122 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 - K183361

510(k) Number K183361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2018
Decision Date April 05, 2019
Days to Decision 122 days
Submission Type Traditional
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
3d faster than avg
Panel avg: 125d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 57
Devices cleared under the same product code (QEY) and FDA review panel - the closest regulatory comparables to K183361.
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
K191119 · Btg International, Inc. · Aug 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
Pulse* Spray Infusion System, Uni*Fuse Infusion System
K163356 · AngioDynamics, Inc. · May 2017