Cleared Traditional

K130569 - ND NABIL DIB INFUSION CATHETER

K130569 is an FDA 510(k) clearance for ND NABIL DIB INFUSION CATHETER, manufactured by Translational Research Institute. The device is a Class 2 Cardiovascular device with product code KRA cleared through the Traditional 510(k) pathway after a 256-day FDA review.

K130569 · Translational Research Institute · Cardiovascular device
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Nov 2013
Decision
256d
Days
Class 2
Risk

K130569 is an FDA 510(k) clearance for the ND NABIL DIB INFUSION CATHETER. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Translational Research Institute (Gilbert, US). The FDA issued a Cleared decision on November 15, 2013 after a review of 256 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 Translational Research Institute devices

FDA 510(k) Submission Details - K130569

510(k) Number K130569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2013
Decision Date November 15, 2013
Days to Decision 256 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
131d slower than avg
Panel avg: 125d · This submission: 256d
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 134
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K130569.
Direxion Torqueable Microcatheter
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K140329 · Boston Scientific · May 2014
CANTATA(R) 2.9 MICROCATHETER
K131772 · Cook, Inc. · Feb 2014
DIREXION AND DIREXION HI-FLO TORQUEABLE MICROCATHETERS
K132947 · Boston Scientific Corp · Oct 2013
CXI SUPPORT CATHETER
K122796 · Cook, Inc. · Oct 2012
ORION MICRO CATHETER
K113289 · Micro Therapeutics, Inc. · Aug 2012