Cleared Traditional

K051990 - ECHELON MICRO CATHETER

K051990 is the FDA 510(k) clearance for ECHELON MICRO CATHETER by Micro Therapeutics, Inc.. It is a Class 2 Cardiovascular device (product code KRA) cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K051990 · Micro Therapeutics, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jan 2006
Decision
166d
Days
Class 2
Risk

K051990 is an FDA 510(k) clearance for the ECHELON 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 January 4, 2006 after a review of 166 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 Micro Therapeutics, Inc. devices

Submission Details

510(k) Number K051990 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 2005
Decision Date January 04, 2006
Days to Decision 166 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
41d slower than avg
Panel avg: 125d · This submission: 166d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 89
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K051990.
CXI SUPPORT CATHETER
K072724 · Cook, Inc. · Nov 2007
PULL TAB SQUEEZE FLUSH
K070979 · Icu Medical, Inc. · Sep 2007
MODIFICATION TO MIRA-FLEX 18 MICROCATHETER
K060224 · Cook Incorporated · Mar 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