Cleared Special

K161801 - CrossCath Support Catheter

K161801 is an FDA 510(k) clearance for CrossCath 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 29-day FDA review.

K161801 · Cook Incorporated · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2016
Decision
29d
Days
Class 2
Risk

K161801 is an FDA 510(k) clearance for the CrossCath 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 July 29, 2016 after a review of 29 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. 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. Low regulatory complexity profile. 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 - K161801

510(k) Number K161801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2016
Decision Date July 29, 2016
Days to Decision 29 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
96d faster than avg
Panel avg: 125d · This submission: 29d
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 K161801.
CXI Support Catheter
K160884 · Cook Incorporated · Nov 2016
SwiftNINJA Microcatheter
K161921 · Merit Medical Systems, Inc. · Nov 2016
Bullfrog Micro-Infusion Device
K161402 · Mercator Medsystems, Inc. · Aug 2016
Bullfrog Micro-Infusion Device
K153501 · Mercator Medsystems, Inc. · Apr 2016
MMS Guide Catheter
K152625 · Micro Medical Solutions, Inc. · Mar 2016
ClariVein IC
K153502 · Vascular Insights, LLC · Jan 2016