Cleared Special

CXI TriForce Peripheral Crossing Set (K170931) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K170931 · Cook Incorporated · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2017
Decision
229d
Days
Class 2
Risk

K170931 is an FDA 510(k) clearance for the CXI TriForce Peripheral Crossing Set. 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 November 13, 2017 after a review of 229 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. 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.

View all Cook Incorporated devices

Submission Details

510(k) Number K170931 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2017
Decision Date November 13, 2017
Days to Decision 229 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
104d slower than avg
Panel avg: 125d · This submission: 229d
Pathway characteristics
Modification to existing cleared device.

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 75
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K170931.
VAMP Optima closed blood sampling system
K180275 · Edwards Lifesciences, LLC · Oct 2018
VAMP Venous/Arterial Blood Management Protection System
K173586 · Edwards Lifesciences, LLC · Apr 2018
Microcatheter and guide-wire system
K171665 · Suzhou Hengrui Disheng Medical Co., Ltd. · Jan 2018
Maestro Microcatheter
K172081 · Merit Medical Systems, Inc. · Aug 2017
Direxion and Direxion HI-FLO Torqueable Microcatheters
K163701 · Boston Scientific Corporation · May 2017
VAMP Venous/Arterial Blood Management Protection System
K161962 · Edwards Lifesciences, LLC · Nov 2016