Cleared Special

K031992 - ECHELON MICRO CATHETER

K031992 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 Special 510(k) pathway after a 41-day FDA review.

K031992 · Micro Therapeutics, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2003
Decision
41d
Days
Class 2
Risk

K031992 is an FDA 510(k) clearance for the ECHELON MICRO CATHETER, MODEL 105-5091. 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 August 7, 2003 after a review of 41 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 K031992 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2003
Decision Date August 07, 2003
Days to Decision 41 days
Submission Type Special
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
84d faster than avg
Panel avg: 125d · This submission: 41d
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 93
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K031992.
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
PROGREAT
K033913 · Terumo Medical Corp. · Mar 2004
MARATHON FLOW DIRECTED MICRO CATHETER, MODEL 105-5055
K034036 · Micro Therapeutics, Inc. · Feb 2004
ECHELON MICRO CATHETER, MODEL 105-5092-150
K030688 · Micro Therapeutics, Inc. · Mar 2003
RENEGADE HI-FLO MICROCATHETER
K000177 · Boston Scientific Corp · Apr 2000
RENEGADE FIBER BRAIDED MICROCATHETER
K973645 · Boston Scientific Corp · Nov 1997