Cleared Special

K090140 - GUNTHER TULIP VENA CAVA FILTER, COOK CELECT VENA CAVA FILTER

K090140 is an FDA 510(k) clearance for GUNTHER TULIP VENA CAVA FILTER, manufactured by William Cook Europe Aps. The device is a Class 2 Cardiovascular device with product code DTK cleared through the Special 510(k) pathway after a 72-day FDA review.

K090140 · William Cook Europe Aps · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2009
Decision
72d
Days
Class 2
Risk

K090140 is an FDA 510(k) clearance for the GUNTHER TULIP VENA CAVA FILTER, COOK CELECT VENA CAVA FILTER. Classified as Filter, Intravascular, Cardiovascular (product code DTK), Class II - Special Controls.

Submitted by William Cook Europe Aps (Bloomington, US). The FDA issued a Cleared decision on April 3, 2009 after a review of 72 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 William Cook Europe Aps devices

FDA 510(k) Submission Details - K090140

510(k) Number K090140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2009
Decision Date April 03, 2009
Days to Decision 72 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
53d faster than avg
Panel avg: 125d · This submission: 72d
Pathway characteristics
Modification to existing cleared device.

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
NCT00196118 Completed Interventional Industry-sponsored

Study of IVC Filter Retrieval With the Günther Tulip Vena Cava Filter

A Non-Randomized Prospective Study of IVC Filter Retrieval

800
Patients (est.)
17
Sites
Open label
Masking
Condition studied Pulmonary Embolism; Venous Thromboembolism
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Bob Smouse, MD
Sponsor Cook Group Incorporated (industry)
Started 2005-04-01 → Completed 2007-07-01
Primary outcome
The rate of successful filter retrieval following implant.
Secondary outcome
The rate of complications related to Inferior Vena Cava Filter use.
Study completed - no results published. This trial concluded in 2007 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
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 K090140.
ECLIPSE FILTER SYSTEM-FEMORAL DELIVERY KIT, ECLIPSE FILTER SYSTEM-JUGULAR/SUBCLAVIAN DELIVERY KIT MODEL RF500F MODEL RF5
K093659 · C.R. Bard, Inc. · Jan 2010
OPTION VENA CAVA FILTER
K081410 · Rex Medical · Jun 2009
SAFEFLO VENA CAVA FILTER
K081138 · Rmt Medical Technilogies, Inc. · May 2009
G2 EXPRESS FILTER SYSTEM - FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS
K082305 · C.R. Bard, Inc. · Oct 2008
G2 EXPRESS FILTER SYSTEM-FEMORAL (RF400F) AND JUGULAR/SUBCLAVIAN (RF400J) DELIVERY KITS
K080668 · C.R. Bard, Inc. · Jul 2008
COOK CLECT VENA CAVA FILTER, GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
K073374 · William Cook Europe Aps · Mar 2008