Cleared Traditional

K010083 - TRAPEASE PERMANENT VENA CAVA FILTER AND...

K010083 is an FDA 510(k) clearance for TRAPEASE PERMANENT VENA CAVA FILTER AND..., manufactured by Cordis Corp.. The device is a Class 2 Cardiovascular device with product code DTK cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K010083 · Cordis Corp. · Cardiovascular device
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Jun 2001
Decision
146d
Days
Class 2
Risk

K010083 is an FDA 510(k) clearance for the TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT, MODEL 466-P306A. Classified as Filter, Intravascular, Cardiovascular (product code DTK), Class II - Special Controls.

Submitted by Cordis Corp. (Warren, US). The FDA issued a Cleared decision on June 6, 2001 after a review of 146 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 Cordis Corp. devices

FDA 510(k) Submission Details - K010083

510(k) Number K010083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 2001
Decision Date June 06, 2001
Days to Decision 146 days
Submission Type Traditional
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
21d slower than avg
Panel avg: 125d · This submission: 146d
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 43
Devices cleared under the same product code (DTK) and FDA review panel - the closest regulatory comparables to K010083.
RECOVERY FILTER SYSTEM, MODEL RF-048F
K031328 · C.R. Bard, Inc. · Jul 2003
RECOVERY FILTER SYSTEM, MODEL RF-048F
K022236 · C.R. Bard, Inc. · Nov 2002
CORDIS OPTEASE PERMANENT VENA CAVA FILTER, MODELS 466-F200A, 466-F200B
K023116 · Cordis Corp. · Oct 2002
TRAPEASE PERMANENT VENA FILTER AND INTRODUCTION KIT, MODELS 466-P306A AND 466-P306B
K003964 · Cordis Corp. · Jan 2001
GUNTHER TULIP VENA CAVA MREYE FILTER SET
K000855 · Cook, Inc. · Oct 2000
CORDIS TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT
K000062 · Cordis Corp. · Jul 2000