Cleared Traditional

K183361 - EkoSonic Endovascular Device with Contr...

K183361 is the FDA 510(k) clearance for EkoSonic Endovascular Device 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 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

Submission Details

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.

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 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