Cleared Special

K080737 - MIRAFLEX HIGH FLOW MICROCATHETER

K080737 is an FDA 510(k) clearance for MIRAFLEX HIGH FLOW MICROCATHETER, manufactured by Cook, Inc.. The device is a Class 2 Cardiovascular device with product code KRA cleared through the Special 510(k) pathway after a 144-day FDA review.

K080737 · Cook, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2008
Decision
144d
Days
Class 2
Risk

K080737 is an FDA 510(k) clearance for the MIRAFLEX HIGH FLOW MICROCATHETER. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on August 8, 2008 after a review of 144 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K080737

510(k) Number K080737 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2008
Decision Date August 08, 2008
Days to Decision 144 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
19d slower than avg
Panel avg: 125d · This submission: 144d
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 176
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K080737.
MERIT MICROCATHETER
K082613 · Merit Medical Systems, Inc. · Dec 2008
FLOWMEDICA BENEPHIT INFUSION SYSTEMS
K082163 · Flowmedica, Inc. · Oct 2008
FINECROSS MG CORONARY MICRO-GUIDE CATHETER
K082519 · Terumo Medical Corp. · Sep 2008
VASCON ROAMER MICROCATHETER
K053310 · Vascon, LLC · Jul 2008
ENDOWAVE INFUSION SYSTEM
K073166 · Ekos Corp. · Apr 2008
CLARIVEIN CATHETER
K071468 · Vascular Insights, LLC · Mar 2008
K080737 · MIRAFLEX HIGH FLOW MICROCATHETER
Download PDF FDA Summary Cook, Inc.