Cleared Special

K160884 - CXI Support Catheter

K160884 is an FDA 510(k) clearance for CXI Support Catheter, manufactured by Cook Incorporated. The device is a Class 2 Cardiovascular device with product code KRA cleared through the Special 510(k) pathway after a 236-day FDA review.

K160884 · Cook Incorporated · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2016
Decision
236d
Days
Class 2
Risk

K160884 is an FDA 510(k) clearance for the CXI Support Catheter. 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 22, 2016 after a review of 236 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.

FDA 510(k) Submission Details - K160884

510(k) Number K160884 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2016
Decision Date November 22, 2016
Days to Decision 236 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
111d slower than avg
Panel avg: 125d · This submission: 236d
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 168
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K160884.
Direxion and Direxion HI-FLO Torqueable Microcatheters
K163701 · Boston Scientific Corporation · May 2017
FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm
K161967 · Callisyn Biomedical, Inc. · Jan 2017
VAMP Venous/Arterial Blood Management Protection System
K161962 · Edwards Lifesciences, LLC · Nov 2016
SwiftNINJA Microcatheter
K161921 · Merit Medical Systems, Inc. · Nov 2016
Bullfrog Micro-Infusion Device
K161402 · Mercator Medsystems, Inc. · Aug 2016
CrossCath Support Catheter
K161801 · Cook Incorporated · Jul 2016