Cleared Traditional

K131446 - INTEGRA JARIT HEPARIN CANNULAS

K131446 is the FDA 510(k) clearance for INTEGRA JARIT HEPARIN CANNULAS by Integra LifeSciences Corporation. It is a Class 2 Cardiovascular device (product code DQR) cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K131446 · Integra LifeSciences Corporation · Cardiovascular device
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Oct 2013
Decision
161d
Days
Class 2
Risk

K131446 is an FDA 510(k) clearance for the INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLES. Classified as Cannula, Catheter (product code DQR), Class II - Special Controls.

Submitted by Integra LifeSciences Corporation (York, US). The FDA issued a Cleared decision on October 28, 2013 after a review of 161 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1300 - 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 Integra LifeSciences Corporation devices

Submission Details

510(k) Number K131446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2013
Decision Date October 28, 2013
Days to Decision 161 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
36d slower than avg
Panel avg: 125d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQR Cannula, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1300
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 - DQR Cannula, Catheter

All 13
Devices cleared under the same product code (DQR) and FDA review panel - the closest regulatory comparables to K131446.
ANGIODYNAMICS, INC., MICRO ACCESS KITS
K051655 · AngioDynamics, Inc. · Sep 2005
RMI INTERNAL MAMMARY ARTERY CANNULA
K960098 · Research Medical, Inc. · Mar 1996
DATASCOPE ARTERIAL CANNULA W/ACCESS PORT
K902674 · Datascope Corp. · Jan 1991
MODIFIED SHILEY FEMORAL VENOUS CANNULA
K894784 · Shiley, Inc. · Mar 1990
RMI ARTERIAL PERFUSION CANNULA
K894243 · Research Medical, Inc. · Sep 1989
DAIG COLLAPSIBLE STERILE SLEEVE
K884478 · Daig Corp. · Feb 1989