Cleared Traditional

K073166 - ENDOWAVE INFUSION SYSTEM

K073166 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 KRA cleared through the Traditional 510(k) pathway after a 165-day FDA review.

K073166 · Ekos Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
165d
Days
Class 2
Risk

K073166 is an FDA 510(k) clearance for the ENDOWAVE INFUSION SYSTEM. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Ekos Corp. (Bothell, US). The FDA issued a Cleared decision on April 22, 2008 after a review of 165 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1210 - 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 - K073166

510(k) Number K073166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received November 09, 2007
Decision Date April 22, 2008
Days to Decision 165 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
40d slower than avg
Panel avg: 125d · This submission: 165d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KRA Device Classification - Class 2, Special Controls

Product Code KRA Catheter, Continuous Flush
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1210
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 - KRA Catheter, Continuous Flush

All 130
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K073166.
MERIT MICROCATHETER
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K072724 · Cook, Inc. · Nov 2007
PULL TAB SQUEEZE FLUSH
K070979 · Icu Medical, Inc. · Sep 2007
MODIFICATION TO HYPERTRANSIT INFUSION CATHETER
K070279 · Cordis Neurovascular, Inc. · Mar 2007