Cleared Traditional

K131772 - CANTATA(R) 2.9 MICROCATHETER

K131772 is an FDA 510(k) clearance for CANTATA 2.9 MICROCATHETER, manufactured by Cook, Inc.. The device is a Class 2 Cardiovascular device with product code KRA cleared through the Traditional 510(k) pathway after a 248-day FDA review.

K131772 · Cook, Inc. · Cardiovascular device
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Feb 2014
Decision
248d
Days
Class 2
Risk

K131772 is an FDA 510(k) clearance for the CANTATA(R) 2.9 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 February 20, 2014 after a review of 248 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Cook, Inc. devices

FDA 510(k) Submission Details - K131772

510(k) Number K131772 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2013
Decision Date February 20, 2014
Days to Decision 248 days
Submission Type Traditional
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
123d slower than avg
Panel avg: 125d · This submission: 248d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 150
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K131772.
Direxion Torqueable Microcatheter
K142259 · Boston Scientific Corp · Sep 2014
RENEGADE HI-FLO MICROCATHETER, MICROCATHETER KIT, FATHOM SYSTEM, FATHOM KIT
K140329 · Boston Scientific · May 2014
PEREGRINE SYSTEM INFUSION CATHETER
K140637 · Ablative Solutions, Inc. · Mar 2014
ND NABIL DIB INFUSION CATHETER
K130569 · Translational Research Institute · Nov 2013
DIREXION AND DIREXION HI-FLO TORQUEABLE MICROCATHETERS
K132947 · Boston Scientific Corp · Oct 2013
VIA MICROCATHETER, VIA PLUS MICROCATHETER
K123477 · Sequent Medical, Inc. · Mar 2013