Cleared Traditional

K874096 - TITANIUM GREENFIELD VENA CAVA FILTER CA...

K874096 is the FDA 510(k) clearance for TITANIUM GREENFIELD VENA CAVA FILTER CA... by Medi-Tech, Inc.. It is a Class 2 Cardiovascular device (product code DTK) cleared through the Traditional 510(k) pathway after a 393-day FDA review.

K874096 · Medi-Tech, Inc. · Cardiovascular device
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Nov 1988
Decision
393d
Days
Class 2
Risk

K874096 is an FDA 510(k) clearance for the TITANIUM GREENFIELD VENA CAVA FILTER CARRIER. Classified as Filter, Intravascular, Cardiovascular (product code DTK), Class II - Special Controls.

Submitted by Medi-Tech, Inc. (Watertown, US). The FDA issued a Cleared decision on November 4, 1988 after a review of 393 days - an unusually long review period, suggesting complex equivalence evaluation.

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

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Submission Details

510(k) Number K874096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1987
Decision Date November 04, 1988
Days to Decision 393 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
268d slower than avg
Panel avg: 125d · This submission: 393d
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.