Cleared Traditional

K130366 - BARD DENALI FILTER SYSTEM- FEMORAL DELIVERY KIT AND JUGULAR DELIVERY KIT

K130366 is an FDA 510(k) clearance for BARD DENALI FILTER SYSTEM- FEMORAL DELI..., manufactured by C.R. Bard, Inc.. The device is a Class 2 Cardiovascular device with product code DTK cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K130366 · C.R. Bard, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2013
Decision
91d
Days
Class 2
Risk

K130366 is an FDA 510(k) clearance for the BARD DENALI FILTER SYSTEM- FEMORAL DELIVERY KIT AND JUGULAR DELIVERY KIT. Classified as Filter, Intravascular, Cardiovascular (product code DTK), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Tempe, US). The FDA issued a Cleared decision on May 15, 2013 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3375 - 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 C.R. Bard, Inc. devices

FDA 510(k) Submission Details - K130366

510(k) Number K130366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2013
Decision Date May 15, 2013
Days to Decision 91 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
34d faster than avg
Panel avg: 125d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

DTK Device Classification - Class 2, Special Controls

Product Code DTK Filter, Intravascular, Cardiovascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3375
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01305564 Completed Interventional Industry-sponsored

A Prospective, Multi-Center Study of the Bard® Denali™ Retrievable Inferior Vena Cava Filter System

A Prospective, Multi-Center Study of the Bard® Denali™ Retrievable Inferior Vena Cava Filter

200
Patients (actual)
22
Sites
Treatment
Purpose
Open label
Masking
Condition studied Pulmonary Embolism
Study design Single group
Eligibility All sexes · 21 Years+
Principal investigator William Stavropoulos, MD
Sponsor C. R. Bard (industry)
Started 2011-06-01 → Primary completion 2015-06-01 → Completed 2015-07-01
Primary outcome
Technical Success of Placement
Secondary outcome
Rate of Recurring Pulmonary Embolism
View full study on ClinicalTrials.gov

Regulatory Peers - DTK Filter, Intravascular, Cardiovascular

All 53
Devices cleared under the same product code (DTK) and FDA review panel - the closest regulatory comparables to K130366.
Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavian Delivery Kit
K160866 · C.R. Bard, Inc. · Apr 2016
Crux Vena Cava Filter System, femoral
K150262 · Volcano Corporation · Apr 2015
Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavain Delivery Kit
K143208 · C.R. Bard, Inc. · Dec 2014
COOK CELECT PLATINUM VENA CAVA FILTER SET FOR FEMORAL APPROACH COOK CELECT PLATIUM VENA CAVA FILTER SET FOR JUGULAR APPR
K121629 · William Cook Europe Aps · Jul 2012
COOK CELECT AND GUNTHER TULIP VENA CAVA FILTER SETS
K121057 · William Cook Europe Aps · May 2012
CUNTHER TULIP(R) VENA CAVA FILTER SET FOR FEMORAL APPROACH, COOK CELECT(R) VENA CAVA FILTER FOR FEMORAL APPROACH
K112119 · William Cook Europe Aps · Mar 2012