Cleared Special

K111490 - MARKSMAN CATHETER, *REFERS TO DIFFERENT CATHETER WORKING LENGHTS, DISTAL SINGLE COILED LENGTHS AND DISTAL SHAFT LENGTHS

K111490 is an FDA 510(k) clearance for MARKSMAN CATHETER, manufactured by Ev3, Inc.. The device is a Class 2 Cardiovascular device with product code KRA cleared through the Special 510(k) pathway after a 108-day FDA review.

K111490 · Ev3, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2011
Decision
108d
Days
Class 2
Risk

K111490 is an FDA 510(k) clearance for the MARKSMAN CATHETER, *REFERS TO DIFFERENT CATHETER WORKING LENGHTS, DISTAL SING.... Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Ev3, Inc. (Menlo Park, US). The FDA issued a Cleared decision on September 16, 2011 after a review of 108 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 - K111490

510(k) Number K111490 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2011
Decision Date September 16, 2011
Days to Decision 108 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
17d faster than avg
Panel avg: 125d · This submission: 108d
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 K111490.
CXI SUPPORT CATHETER
K122796 · Cook, Inc. · Oct 2012
ORION MICRO CATHETER
K113289 · Micro Therapeutics, Inc. · Aug 2012
ST JUDE MEDICAL, IS4 FLUSHING/FUNNELING TOOL
K113773 · St Jude Medical · Jan 2012
CXI TRIFORCE
K111263 · Cook Incorporated · Jul 2011
CANTATA MICROCATHETER
K101450 · Cook, Inc. · Dec 2010
RENEGADE HI-FLO FATHOM KIT MODEL M001182XXX
K100892 · Boston Scientific Corp · Apr 2010
K111490 · MARKSMAN CATHETER, *REFERS TO DIFFERENT CATHETER WORKING LENGHTS, DISTAL SINGLE COILED LENGTHS AND DISTAL SHAFT LENGTHS
Download PDF FDA Summary Ev3, Inc.