Cleared Special

K024118 - ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, MODELS 105-5065 AND 105-5066

K024118 is an FDA 510(k) clearance for ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, manufactured by Micro Therapeutics, Inc.. The device is a Class 2 Cardiovascular device with product code KRA cleared through the Special 510(k) pathway after a 49-day FDA review.

K024118 · Micro Therapeutics, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2003
Decision
49d
Days
Class 2
Risk

K024118 is an FDA 510(k) clearance for the ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, MODELS 105-5065 AND 105-5066. 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 3, 2003 after a review of 49 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

FDA 510(k) Submission Details - K024118

510(k) Number K024118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2002
Decision Date February 03, 2003
Days to Decision 49 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
76d faster than avg
Panel avg: 125d · This submission: 49d
Pathway characteristics
Modification to existing cleared device.

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 K024118.
ECHELON MICRO CATHETER, MODEL 105-5091
K031992 · Micro Therapeutics, Inc. · Aug 2003
ECHELON MICRO CATHETER, MODEL 105-5092-150
K030688 · Micro Therapeutics, Inc. · Mar 2003
NAUTICA MICRO CATHETER, MODEL 105-5094-153
K024122 · Micro Therapeutics, Inc. · Mar 2003
PROWLER SELECT (10, 14, AND PLUS) INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS
K021591 · Cordis Neurovascular, Inc. · May 2002
PROWLER SELECT 10 AND 14 INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS
K020680 · Cordis Neurovascular, Inc. · Mar 2002
FLOWRIDER FLOW DIRECTED MICRO CATHETER, MODEL 105-5065
K010004 · Micro Therapeutics, Inc. · Feb 2001