Cleared Special

K143208 - Denali Filter System - Femoral Delivery...

K143208 is the FDA 510(k) clearance for Denali Filter System - Femoral Delivery... by C.R. Bard, Inc.. It is a Class 2 Cardiovascular device (product code DTK) cleared through the Special 510(k) pathway after a 29-day FDA review.

K143208 · C.R. Bard, Inc. · Cardiovascular device
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Dec 2014
Decision
29d
Days
Class 2
Risk

K143208 is an FDA 510(k) clearance for the Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/S.... 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 December 9, 2014 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3375 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all C.R. Bard, Inc. devices

Submission Details

510(k) Number K143208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 2014
Decision Date December 09, 2014
Days to Decision 29 days
Submission Type Special
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
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

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 K143208.
Sentry IVC Filter
K173236 · Novate Medical , Ltd. · Feb 2018
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
BARD DENALI FILTER SYSTEM- FEMORAL DELIVERY KIT AND JUGULAR DELIVERY KIT
K130366 · C.R. Bard, Inc. · May 2013
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