Cleared Special

K090140 - GUNTHER TULIP 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
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. 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 K090140.
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