Cleared Traditional

K130366 - BARD DENALI FILTER SYSTEM- FEMORAL DELI...

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

K130366 · C.R. Bard, Inc. · Cardiovascular device
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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

Submission Details

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.

Device Classification

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 38
Devices cleared under the same product code (DTK) and FDA review panel - the closest regulatory comparables to K130366.
Gianturco-Roehm Bird’s Nest Vena Cava Filter
K161218 · Cook Incorporated · Jul 2016
Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavian Delivery Kit
K160866 · C.R. Bard, Inc. · Apr 2016
Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavain Delivery Kit
K143208 · C.R. Bard, Inc. · Dec 2014
MERIDIAN FILTER SYSTEM - FEMORAL DELIVERY KIT
K112497 · C.R. Bard, Inc. · Oct 2011
MERIDAN FILTER SYSTEM- JUNGULAR/SUBECLAVIAN DELIVERY KIT
K102511 · C.R. Bard, Inc. · Aug 2011
ECLIPSE FILTER SYSTEM-FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS
K101431 · C.R. Bard, Inc. · Jun 2010