Cleared Special

K101450 - CANTATA MICROCATHETER

K101450 is an FDA 510(k) clearance for CANTATA MICROCATHETER, manufactured by Cook, Inc.. The device is a Class 2 Cardiovascular device with product code KRA cleared through the Special 510(k) pathway after a 220-day FDA review.

K101450 · Cook, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2010
Decision
220d
Days
Class 2
Risk

K101450 is an FDA 510(k) clearance for the CANTATA MICROCATHETER. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on December 30, 2010 after a review of 220 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 - K101450

510(k) Number K101450 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2010
Decision Date December 30, 2010
Days to Decision 220 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
95d slower than avg
Panel avg: 125d · This submission: 220d
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 176
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K101450.
ST JUDE MEDICAL, IS4 FLUSHING/FUNNELING TOOL
K113773 · St Jude Medical · Jan 2012
MARKSMAN CATHETER, *REFERS TO DIFFERENT CATHETER WORKING LENGHTS, DISTAL SINGLE COILED LENGTHS AND DISTAL SHAFT LENGTHS
K111490 · Ev3, Inc. · Sep 2011
CXI TRIFORCE
K111263 · Cook Incorporated · Jul 2011
RENEGADE HI-FLO FATHOM KIT MODEL M001182XXX
K100892 · Boston Scientific Corp · Apr 2010
ECHELON MICRO CATHETER, MARATHON MICRO CATHETER, NAUTICA MICRO CATHETER ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, REBA
K093750 · Ev3, Inc. · Dec 2009
CROSSCATH SUPPORT CATHTER
K093052 · Cook, Inc. · Dec 2009
K101450 · CANTATA MICROCATHETER
Download PDF FDA Summary Cook, Inc.