Cleared Traditional

K964284 - STAINLESS STEEL GREENFIELD VENA CAVA FI...

K964284 is the FDA 510(k) clearance for STAINLESS STEEL GREENFIELD VENA CAVA FI... by Boston Scientific Corp. It is a Class 2 Cardiovascular device (product code DTK) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K964284 · Boston Scientific Corp · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1997
Decision
70d
Days
Class 2
Risk

K964284 is an FDA 510(k) clearance for the STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F INTRODUCER SYSTEM. Classified as Filter, Intravascular, Cardiovascular (product code DTK), Class II - Special Controls.

Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on January 6, 1997 after a review of 70 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 Boston Scientific Corp devices

Submission Details

510(k) Number K964284 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1996
Decision Date January 06, 1997
Days to Decision 70 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
55d faster than avg
Panel avg: 125d · This submission: 70d
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 42
Devices cleared under the same product code (DTK) and FDA review panel - the closest regulatory comparables to K964284.
TRAPEASE PERMANENT VENA FILTER AND INTRODUCTION KIT, MODELS 466-P306A AND 466-P306B
K003964 · Cordis Corp. · Jan 2001
GUNTHER TULIP VENA CAVA MREYE FILTER SET
K000855 · Cook, Inc. · Oct 2000
CORDIS TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT
K000062 · Cordis Corp. · Jul 2000
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