Cleared Traditional

K073374 - COOK CLECT VENA CAVA FILTER

K073374 is an FDA 510(k) clearance for COOK CLECT VENA CAVA FILTER, 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 95-day FDA review.

K073374 · William Cook Europe Aps · Cardiovascular device
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Mar 2008
Decision
95d
Days
Class 2
Risk

K073374 is an FDA 510(k) clearance for the COOK CLECT VENA CAVA FILTER, GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET. 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 March 7, 2008 after a review of 95 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all William Cook Europe Aps devices

FDA 510(k) Submission Details - K073374

510(k) Number K073374 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2007
Decision Date March 07, 2008
Days to Decision 95 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 125d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K073374.
ECLIPSE FILTER SYSTEM-FEMORAL DELIVERY KIT, ECLIPSE FILTER SYSTEM-JUGULAR/SUBCLAVIAN DELIVERY KIT MODEL RF500F MODEL RF5
K093659 · C.R. Bard, Inc. · Jan 2010
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
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
GUNTHER TULIP VENA CAVA FILTER
K072240 · Cook, Inc. · Nov 2007