Cleared Special

CrossCath Support Catheter (K161801) - FDA 510(k) Clearance

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

K161801 · Cook Incorporated · Cardiovascular device
Download Printable Device Report (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.

View all Cook Incorporated devices

Submission Details

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.

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 K161801.
VAMP Venous/Arterial Blood Management Protection System
K161962 · Edwards Lifesciences, LLC · Nov 2016
CXI Support Catheter
K160884 · Cook Incorporated · Nov 2016
SwiftNINJA Microcatheter
K161921 · Merit Medical Systems, Inc. · Nov 2016
Direxion Torqueable Microcatheter
K142259 · Boston Scientific Corp · Sep 2014
CANTATA(R) 2.9 MICROCATHETER
K131772 · Cook, Inc. · Feb 2014
DIREXION AND DIREXION HI-FLO TORQUEABLE MICROCATHETERS
K132947 · Boston Scientific Corp · Oct 2013