Cleared Traditional

K111705 - EKOSONIC ENDOVASCULAR SYSTEM

K111705 is an FDA 510(k) clearance for EKOSONIC ENDOVASCULAR SYSTEM, manufactured by Ekos Corporation. The device is a Class 2 Cardiovascular device with product code QEY cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K111705 · Ekos Corporation · Cardiovascular device
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Aug 2011
Decision
47d
Days
Class 2
Risk

K111705 is an FDA 510(k) clearance for the EKOSONIC ENDOVASCULAR SYSTEM. Classified as Mechanical Thrombolysis Catheter (product code QEY), Class II - Special Controls.

Submitted by Ekos Corporation (Bothell, US). The FDA issued a Cleared decision on August 3, 2011 after a review of 47 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ekos Corporation devices

FDA 510(k) Submission Details - K111705

510(k) Number K111705 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2011
Decision Date August 03, 2011
Days to Decision 47 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
78d faster than avg
Panel avg: 125d · This submission: 47d
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 K111705.
Occlusion Perfusion Catheter
K151554 · Advanced Catheter Therapies, Inc. · Sep 2015
EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT
K140151 · Btg International, Inc. · May 2014
TRELLIS-8 PERIPHERAL INFUSION SYSTEM
K130904 · Covidien · Oct 2013
EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATION
K081467 · Ekos Corp. · Jun 2008
EndoWave Infusion System
K080392 · Ekos Corp. · Apr 2008
ENDOWAVE INFUSION SYSTEM
K072507 · Ekos Corp. · Oct 2007