Cleared Special

K042187 - ECHELON 10

K042187 is the FDA 510(k) clearance for ECHELON 10 by Micro Therapeutics, Inc.. It is a Class 2 Cardiovascular device (product code KRA) cleared through the Special 510(k) pathway after a 21-day FDA review.

K042187 · Micro Therapeutics, Inc. · Cardiovascular device
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Sep 2004
Decision
21d
Days
Class 2
Risk

K042187 is an FDA 510(k) clearance for the ECHELON 10,45 TIP SHAPE MICRO CATHETER ECHELON 10,90 TIP SHAPE MICRO CATHETER.... Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Micro Therapeutics, Inc. (Irvine, US). The FDA issued a Cleared decision on September 2, 2004 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1210 - 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 Micro Therapeutics, Inc. devices

Submission Details

510(k) Number K042187 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2004
Decision Date September 02, 2004
Days to Decision 21 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 125d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 90
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K042187.
MODIFICATION TO MIRA-FLEX 18 MICROCATHETER
K060224 · Cook Incorporated · Mar 2006
ECHELON MICRO CATHETER
K051990 · Micro Therapeutics, Inc. · Jan 2006
MIRA-FLEX 18 MICROCATHETER
K052841 · Cook, Inc. · Dec 2005
PROGREAT
K033913 · Terumo Medical Corp. · Mar 2004
RENEGADE HI-FLO MICROCATHETER
K000177 · Boston Scientific Corp · Apr 2000
RENEGADE FIBER BRAIDED MICROCATHETER
K973645 · Boston Scientific Corp · Nov 1997