Cleared Traditional

K112119 - CUNTHER TULIP VENA CAVA FILTER SET FOR ...

K112119 is an FDA 510(k) clearance for CUNTHER TULIP VENA CAVA FILTER SET FOR ..., 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 249-day FDA review.

K112119 · William Cook Europe Aps · Cardiovascular device
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Mar 2012
Decision
249d
Days
Class 2
Risk

K112119 is an FDA 510(k) clearance for the CUNTHER TULIP(R) VENA CAVA FILTER SET FOR FEMORAL APPROACH, COOK CELECT(R) VE.... Classified as Filter, Intravascular, Cardiovascular (product code DTK), Class II - Special Controls.

Submitted by William Cook Europe Aps (West Lafayette, US). The FDA issued a Cleared decision on March 30, 2012 after a review of 249 days - an extended review 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: 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 - K112119

510(k) Number K112119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2011
Decision Date March 30, 2012
Days to Decision 249 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
124d slower than avg
Panel avg: 125d · This submission: 249d
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 K112119.
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ECLIPSE FILTER SYSTEM-FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS
K101431 · C.R. Bard, Inc. · Jun 2010