Cleared Traditional

VENA CAVA FILTER (K901454) - FDA 510(k) Clearance

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

K901454 · Vena-Tech, Inc. · Cardiovascular device
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May 1991
Decision
428d
Days
Class 2
Risk

K901454 is an FDA 510(k) clearance for the VENA CAVA FILTER. Classified as Filter, Intravascular, Cardiovascular (product code DTK), Class II - Special Controls.

Submitted by Vena-Tech, Inc. (Evanston, US). The FDA issued a Cleared decision on May 29, 1991 after a review of 428 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Vena-Tech, Inc. devices

Submission Details

510(k) Number K901454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1990
Decision Date May 29, 1991
Days to Decision 428 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
303d slower than avg
Panel avg: 125d · This submission: 428d
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 39
Devices cleared under the same product code (DTK) and FDA review panel - the closest regulatory comparables to K901454.
STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F FLEXCARRIER INTRODUCTER SYSTEM
K955396 · Boston Scientific Corp · Feb 1996
STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 24F INTRODUCER SYSTEM
K951508 · Boston Scientific Corp · Jun 1995
STAINLESS STEEL GREEN VENA CAVA FILT W/12F INTR SY
K912035 · Boston Scientific Corp · Jun 1995
TITANIUM GREENFIELD(R) VENA CAVA FILTER W/HOOKS
K901659 · Boston Scientific Corp · Nov 1990
GREENFIELD VENA CAVA FILTER W/19.5 FR INTRODUCER
K901235 · Boston Scientific Corp · Oct 1990