Cleared Special

FLOWRIDER FLOW DIRECTED MICRO CATHETER, MODEL 105-5065 (K010004) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K010004 · Micro Therapeutics, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
42d
Days
Class 2
Risk

K010004 is an FDA 510(k) clearance for the FLOWRIDER FLOW DIRECTED MICRO CATHETER, MODEL 105-5065. 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 February 13, 2001 after a review of 42 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 K010004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2001
Decision Date February 13, 2001
Days to Decision 42 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
83d faster than avg
Panel avg: 125d · This submission: 42d
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 173
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