Cleared Traditional

K051990 - ECHELON MICRO CATHETER

K051990 is an FDA 510(k) clearance for ECHELON MICRO CATHETER, manufactured by Micro Therapeutics, Inc.. The device is a Class 2 Cardiovascular device with 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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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

FDA 510(k) Submission Details - K051990

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.

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 139
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K051990.
ARGON CONTINUOUS FLUSH DEVICE
K070384 · Argon Medical Devices, Inc. · Mar 2007
MODIFICATION TO HYPERTRANSIT INFUSION CATHETER
K070279 · Cordis Neurovascular, Inc. · Mar 2007
MODIFICATION TO MIRA-FLEX 18 MICROCATHETER
K060224 · Cook Incorporated · Mar 2006
MIRA-FLEX 18 MICROCATHETER
K052841 · Cook, Inc. · Dec 2005
HYPERTRANSIT INFUSION CATHETER
K043538 · Cordis Neurovascular, Inc. · Apr 2005
ECHELON 10,45 TIP SHAPE MICRO CATHETER ECHELON 10,90 TIP SHAPE MICRO CATHETER, ECHELON 14,45 TIP SHAPE MICRO CATHETER,90
K042187 · Micro Therapeutics, Inc. · Sep 2004