Cleared Traditional

K032426 - GUNHTER TULIP VENA CAVA MREYE FILTER AN...

K032426 is the FDA 510(k) clearance for GUNHTER TULIP VENA CAVA MREYE FILTER AN... by Cook, Inc.. It is a Class 2 Cardiovascular device (product code DTK) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K032426 · Cook, Inc. · Cardiovascular device
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Oct 2003
Decision
86d
Days
Class 2
Risk

K032426 is an FDA 510(k) clearance for the GUNHTER TULIP VENA CAVA MREYE FILTER AND RETRIEVAL SET. 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 October 31, 2003 after a review of 86 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cook, Inc. devices

Submission Details

510(k) Number K032426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2003
Decision Date October 31, 2003
Days to Decision 86 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
39d faster than avg
Panel avg: 125d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K032426.
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
GUNTHER TULIP VENA CAVA FILTER SET
K043509 · Cook, Inc. · May 2005
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