Cleared Traditional

K974473 - EASY RIDER MICRO CATHETER

K974473 is an FDA 510(k) clearance for EASY RIDER 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 203-day FDA review.

K974473 · Micro Therapeutics, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1998
Decision
203d
Days
Class 2
Risk

K974473 is an FDA 510(k) clearance for the EASY RIDER MICRO CATHETER. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Micro Therapeutics, Inc. (San Clemente, US). The FDA issued a Cleared decision on June 17, 1998 after a review of 203 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 - K974473

510(k) Number K974473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1997
Decision Date June 17, 1998
Days to Decision 203 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
78d slower than avg
Panel avg: 125d · This submission: 203d
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 K974473.
REBAR MICRO CATHETER, MODELS 105-5080, 105-5086
K993672 · Micro Therapeutics, Inc. · Jan 2000
PROWLER PLUS INFUSION CATHETER
K993266 · Cordis Neurovascular, Inc. · Oct 1999
1 MASS TRANSIT INFUSION CATHETER, 1 VARIOUS
K983003 · Cordis Neurovascular, Inc. · Sep 1998
FLOW RIDER FLOW DIRECTED MICRO CATHETER
K980104 · Micro Therapeutics, Inc. · Apr 1998
MICROFUSE MEMBRANE INFUSION CATHETER
K971619 · E-Med Corp. · Feb 1998
CES MASSTRANSIT INFUSION CATHETER
K974222 · Cordis Neurovascular, Inc. · Feb 1998