Cleared Traditional

K171712 - Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Jugular Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach

K171712 is an FDA 510(k) clearance for Cook Celect Platinum Vena Cava Filter S..., manufactured by William Cook Europe Aps. The device is a Class 2 Cardiovascular device with product code DTK cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K171712 · William Cook Europe Aps · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2017
Decision
59d
Days
Class 2
Risk

K171712 is an FDA 510(k) clearance for the Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Cel.... Classified as Filter, Intravascular, Cardiovascular (product code DTK), Class II - Special Controls.

Submitted by William Cook Europe Aps (Bjaeverskov, DK). The FDA issued a Cleared decision on August 7, 2017 after a review of 59 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all William Cook Europe Aps devices

FDA 510(k) Submission Details - K171712

510(k) Number K171712 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2017
Decision Date August 07, 2017
Days to Decision 59 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
66d faster than avg
Panel avg: 125d · This submission: 59d
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
NCT00470626 Completed Interventional Industry-sponsored

Celect Vena Cava Filter Clinical Trial

Prospective Study of the Cook Celect Filter, Including Permanent and Retrievable Use

129
Patients (actual)
8
Sites
Treatment
Purpose
Open label
Masking
Condition studied Pulmonary Embolism; Venous Thromboembolism
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator R.W. Gunther, Prof.
Sponsor Cook Group Incorporated (industry)
Started 2005-11-01 → Primary completion 2009-03-01
Primary outcome
Major Adverse Event
Secondary outcome
Successful Retrieval
View full study on ClinicalTrials.gov

Regulatory Peers - DTK Filter, Intravascular, Cardiovascular

All 70
Devices cleared under the same product code (DTK) and FDA review panel - the closest regulatory comparables to K171712.
Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach
K172557 · William Cook Europe Aps · Nov 2017
Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach
K172584 · William Cook Europe Aps · Nov 2017
ALN Optional Vena Cava Filter - Femoral Approach, ALN Optional Vena Cava Filter - Jugular Approach, ALN Optional Vena Cava Filter - Brachial Approach, ALN Optional Vena Cava Filter - Femoral Approach with Hook
K163699 · Aln Implants Chirurgicaux · Sep 2017
Sentry IVC filter
K162875 · Novate Medical , Ltd. · Feb 2017
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