Cleared Abbreviated

K163699 - ALN Optional Vena Cava Filter - Femoral...

K163699 is an FDA 510(k) clearance for ALN Optional Vena Cava Filter - Femoral..., manufactured by Aln Implants Chirurgicaux. The device is a Class 2 Cardiovascular device with product code DTK cleared through the Abbreviated 510(k) pathway after a 253-day FDA review.

K163699 · Aln Implants Chirurgicaux · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Sep 2017
Decision
253d
Days
Class 2
Risk

K163699 is an FDA 510(k) clearance for the ALN Optional Vena Cava Filter - Femoral Approach, ALN Optional Vena Cava Filt.... Classified as Filter, Intravascular, Cardiovascular (product code DTK), Class II - Special Controls.

Submitted by Aln Implants Chirurgicaux (Bormes Les Mimosas, FR). The FDA issued a Cleared decision on September 8, 2017 after a review of 253 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3375 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Aln Implants Chirurgicaux devices

FDA 510(k) Submission Details - K163699

510(k) Number K163699 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2016
Decision Date September 08, 2017
Days to Decision 253 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
128d slower than avg
Panel avg: 125d · This submission: 253d
Pathway characteristics
Standards-based clearance path.

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. 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 44
Devices cleared under the same product code (DTK) and FDA review panel - the closest regulatory comparables to K163699.
Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum Vena Cava Filte Set for Jugular Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach
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Sentry IVC Filter
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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
Crux Vena Cava Filter System, femoral
K150262 · Volcano Corporation · Apr 2015