Cleared Special

K072240 - GUNTHER TULIP VENA CAVA FILTER

K072240 is the FDA 510(k) clearance for GUNTHER TULIP VENA CAVA FILTER by Cook, Inc.. It is a Class 2 Cardiovascular device (product code DTK) cleared through the Special 510(k) pathway after a 87-day FDA review.

K072240 · Cook, Inc. · Cardiovascular device
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Nov 2007
Decision
87d
Days
Class 2
Risk

K072240 is an FDA 510(k) clearance for the GUNTHER TULIP VENA CAVA FILTER. Classified as Filter, Intravascular, Cardiovascular (product code DTK), Class II - Special Controls.

Submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on November 8, 2007 after a review of 87 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 Cook, Inc. devices

Submission Details

510(k) Number K072240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2007
Decision Date November 08, 2007
Days to Decision 87 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
38d faster than avg
Panel avg: 125d · This submission: 87d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 43
Devices cleared under the same product code (DTK) and FDA review panel - the closest regulatory comparables to K072240.
G2 EXPRESS FILTER SYSTEM-FEMORAL (RF400F) AND JUGULAR/SUBCLAVIAN (RF400J) DELIVERY KITS
K080668 · C.R. Bard, Inc. · Jul 2008
VENA CAVA FILTER
K073528 · Cook Incorporated · Feb 2008
RECOVERY G2 FILTER SYSTEM - FEMORAL DELIVERY KIT, MODEL RF-310F
K073090 · C.R. Bard, Inc. · Jan 2008
VENATECH LP BRACHIAL INTRODUCER SYSTEM (ANTECUBITAL)
K063217 · B.Braun Medical, Inc. · Jan 2007
BARD G2 FILTER SYSTEM - JUGULAR/SUBCLAVIAN DELIVERY KIT, MODEL RF-320J
K052578 · Bard Peripheral Vascular, Inc. · Nov 2005
MODIFICATION TO: RECOVERY FILTER SYSTEM, MODEL RF-210F
K050558 · C.R. Bard, Inc. · Aug 2005