Aln Optional Vana Cava Filter

FDA 510(k) K113124 · Aln Implants Chirurgicaux

Substantially Equivalent

510(k) numberK113124

Submission

Device name
Aln Optional Vana Cava Filter
Applicant
Aln Implants Chirurgicaux
Jarnac, FR
Received
October 21, 2011
Decision date
November 9, 2012
Decision
Substantially Equivalent (SESE)
Type
Abbreviated 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DTK – Filter, Intravascular, Cardiovascular
Device class
Class II (moderate risk)
Regulation
21 CFR 870.3375
Specialty
Cardiovascular
Implant
Yes

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K233680Celect Platinum Vena Cava Filter Set for Femoral Vein Approach…DTK · Traditional William Cook Europe Aps01/18/2024SE
K211875Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect…DTK · Special William Cook Europe Aps07/28/2021SE
K211874Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava…DTK · Special William Cook Europe Aps07/28/2021SE
K181202Sentry IVC FilterDTK · Special Novate Medical , Ltd.06/06/2018SE
K173236Sentry IVC FilterDTK · Traditional Novate Medical , Ltd.02/22/2018SE
K172584Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava…DTK · Traditional William Cook Europe Aps11/20/2017SE

More from William Cook Europe Aps

510(k)DeviceDecision
K163699ALN Optional Vena Cava Filter - Femoral Approach, ALN Optional Vena Cava Filter -…DTK · Abbreviated 09/08/2017SE
K070514Aln Optional Vena Cava Filter-Femoral Approach, Jugular Approach, Brachial Approach…DTK · Abbreviated 01/30/2008SE

Questions and answers

When was Aln Optional Vana Cava Filter cleared by the FDA?

Aln Optional Vana Cava Filter (K113124) received a 510(k) decision of Substantially Equivalent on November 9, 2012, 385 days after the submission was received.

What is the product code of K113124?

The FDA product code is DTK – Filter, Intravascular, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.3375.