Cleared Traditional

K063620 - EKOS MICRO-INFUSION SYSTEM

K063620 is an FDA 510(k) clearance for EKOS MICRO-INFUSION SYSTEM, manufactured by Ekos Corp.. The device is a Class 2 Cardiovascular device with product code QEY cleared through the Traditional 510(k) pathway after a 244-day FDA review.

K063620 · Ekos Corp. · Cardiovascular device
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Aug 2007
Decision
244d
Days
Class 2
Risk

K063620 is an FDA 510(k) clearance for the EKOS MICRO-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 August 6, 2007 after a review of 244 days - an extended review 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: 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 Ekos Corp. devices

FDA 510(k) Submission Details - K063620

510(k) Number K063620 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received December 05, 2006
Decision Date August 06, 2007
Days to Decision 244 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
119d slower than avg
Panel avg: 125d · This submission: 244d
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 46
Devices cleared under the same product code (QEY) and FDA review panel - the closest regulatory comparables to K063620.
EndoWave Infusion System
K080392 · Ekos Corp. · Apr 2008
ENDOWAVE INFUSION SYSTEM
K072507 · Ekos Corp. · Oct 2007
ENDOWAVE INFUSION SYSTEM
K071933 · Ekos Corp. · Aug 2007
MICRO-INFUSION SYSTEM
K062507 · Ekos Corp. · Nov 2006
LYSUS INFUSION SYSTEM
K060422 · Ekos Corp. · Mar 2006
LYSUS INFUSION SYSTEM
K060084 · Ekos Corp. · Feb 2006