Cleared Traditional

K964284 - STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F INTRODUCER SYSTEM

K964284 is an FDA 510(k) clearance for STAINLESS STEEL GREENFIELD VENA CAVA FI..., manufactured by Boston Scientific Corp. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K964284

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.

DTK Device Classification - Class 2, Special Controls

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 64
Devices cleared under the same product code (DTK) and FDA review panel - the closest regulatory comparables to K964284.
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
SIMON NITINOL FILTER/STRAIGHT LINE SYSTEM
K970099 · Nitinol Medical Technologies, Inc. · Apr 1997
SIMON NITINOL FILTER/STRAIGHT LINE SYSTEM
K963014 · Nitinol Medical Technologies, Inc. · Nov 1996
SIMON NITINOL FILTER SYSTEM
K963016 · Nitinol Medical Technologies, Inc. · Nov 1996
STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F FLEXCARRIER INTRODUCTER SYSTEM
K955396 · Boston Scientific Corp · Feb 1996