Cleared Traditional

SIMON NITINOL FILTER SYSTEM (K963016) - FDA 510(k) Clearance

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

K963016 · Nitinol Medical Technologies, Inc. · Cardiovascular device
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Nov 1996
Decision
108d
Days
Class 2
Risk

K963016 is an FDA 510(k) clearance for the SIMON NITINOL FILTER SYSTEM. Classified as Filter, Intravascular, Cardiovascular (product code DTK), Class II - Special Controls.

Submitted by Nitinol Medical Technologies, Inc. (Boston, US). The FDA issued a Cleared decision on November 18, 1996 after a review of 108 days - within the typical 510(k) review window.

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

View all Nitinol Medical Technologies, Inc. devices

Submission Details

510(k) Number K963016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1996
Decision Date November 18, 1996
Days to Decision 108 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 125d · This submission: 108d
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 K963016.
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 INTRODUCER SYSTEM
K964284 · Boston Scientific Corp · Jan 1997
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