Cleared Traditional

K113289 - ORION MICRO CATHETER

K113289 is an FDA 510(k) clearance for ORION 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 268-day FDA review.

K113289 · Micro Therapeutics, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2012
Decision
268d
Days
Class 2
Risk

K113289 is an FDA 510(k) clearance for the ORION MICRO CATHETER. 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 August 1, 2012 after a review of 268 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 - K113289

510(k) Number K113289 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2011
Decision Date August 01, 2012
Days to Decision 268 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
143d slower than avg
Panel avg: 125d · This submission: 268d
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 K113289.
CANTATA(R) 2.9 MICROCATHETER
K131772 · Cook, Inc. · Feb 2014
DIREXION AND DIREXION HI-FLO TORQUEABLE MICROCATHETERS
K132947 · Boston Scientific Corp · Oct 2013
CXI SUPPORT CATHETER
K122796 · Cook, Inc. · Oct 2012
ST JUDE MEDICAL, IS4 FLUSHING/FUNNELING TOOL
K113773 · St Jude Medical · Jan 2012
MARKSMAN CATHETER, *REFERS TO DIFFERENT CATHETER WORKING LENGHTS, DISTAL SINGLE COILED LENGTHS AND DISTAL SHAFT LENGTHS
K111490 · Ev3, Inc. · Sep 2011
CXI TRIFORCE
K111263 · Cook Incorporated · Jul 2011