Cleared Traditional

K870729 - TITANIUM PERCUTANEOUS GREENFIELD VENA C...

K870729 is the FDA 510(k) clearance for TITANIUM PERCUTANEOUS GREENFIELD VENA C... by Medi-Tech, Inc.. It is a Class 2 Cardiovascular device (product code DTK) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K870729 · Medi-Tech, Inc. · Cardiovascular device
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Apr 1987
Decision
43d
Days
Class 2
Risk

K870729 is an FDA 510(k) clearance for the TITANIUM PERCUTANEOUS GREENFIELD VENA CAVE FILTER. 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 April 9, 1987 after a review of 43 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 Medi-Tech, Inc. devices

Submission Details

510(k) Number K870729 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1987
Decision Date April 09, 1987
Days to Decision 43 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 125d · This submission: 43d
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.