Cleared Traditional

K000855 - GUNTHER TULIP VENA CAVA MREYE FILTER SET (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K000855 · Cook, Inc. · Cardiovascular device
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Oct 2000
Decision
216d
Days
Class 2
Risk

K000855 is an FDA 510(k) clearance for the GUNTHER TULIP VENA CAVA MREYE FILTER 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 18, 2000 after a review of 216 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 Cook, Inc. devices

Submission Details

510(k) Number K000855 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2000
Decision Date October 18, 2000
Days to Decision 216 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
91d slower than avg
Panel avg: 125d · This submission: 216d
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 82
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