Cleared Special

K080392 - EndoWave Infusion System

K080392 is an FDA 510(k) clearance for EndoWave Infusion System, manufactured by Ekos Corp.. The device is a Class 2 Cardiovascular device with product code QEY cleared through the Special 510(k) pathway after a 77-day FDA review.

K080392 · Ekos Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
77d
Days
Class 2
Risk

K080392 is an FDA 510(k) clearance for the EndoWave Infusion System. Classified as Mechanical Thrombolysis Catheter (product code QEY), Class II - Special Controls.

Submitted by Ekos Corp. (Bothell, US). The FDA issued a Cleared decision on April 30, 2008 after a review of 77 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. 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ekos Corp. devices

FDA 510(k) Submission Details - K080392

510(k) Number K080392 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2008
Decision Date April 30, 2008
Days to Decision 77 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
48d faster than avg
Panel avg: 125d · This submission: 77d
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 46
Devices cleared under the same product code (QEY) and FDA review panel - the closest regulatory comparables to K080392.
Squirt Fluid Delivery System
K162777 · Merit Medical Systems, Inc. · Oct 2016
TRELLIS-8 PERIPHERAL INFUSION SYSTEM
K130904 · Covidien · Oct 2013
EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATION
K081467 · Ekos Corp. · Jun 2008
ENDOWAVE INFUSION SYSTEM
K072507 · Ekos Corp. · Oct 2007
ENDOWAVE INFUSION SYSTEM
K071933 · Ekos Corp. · Aug 2007
EKOS MICRO-INFUSION SYSTEM
K063620 · Ekos Corp. · Aug 2007