Cleared Traditional

K111263 - CXI TRIFORCE

K111263 is the FDA 510(k) clearance for CXI TRIFORCE by Cook Incorporated. It is a Class 2 Cardiovascular device (product code KRA) cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K111263 · Cook Incorporated · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2011
Decision
82d
Days
Class 2
Risk

K111263 is an FDA 510(k) clearance for the CXI TRIFORCE. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on July 25, 2011 after a review of 82 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cook Incorporated devices

Submission Details

510(k) Number K111263 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2011
Decision Date July 25, 2011
Days to Decision 82 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
43d faster than avg
Panel avg: 125d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 108
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K111263.
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
CANTATA MICROCATHETER
K101450 · Cook, Inc. · Dec 2010
RENEGADE HI-FLO FATHOM KIT MODEL M001182XXX
K100892 · Boston Scientific Corp · Apr 2010
CROSSCATH SUPPORT CATHTER
K093052 · Cook, Inc. · Dec 2009