Cleared Traditional

K901659 - TITANIUM GREENFIELD(R) VENA CAVA FILTER W/HOOKS

K901659 is an FDA 510(k) clearance for TITANIUM GREENFIELD VENA CAVA FILTER W/..., 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 212-day FDA review.

K901659 · Boston Scientific Corp · Cardiovascular device
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Nov 1990
Decision
212d
Days
Class 2
Risk

K901659 is an FDA 510(k) clearance for the TITANIUM GREENFIELD(R) VENA CAVA FILTER W/HOOKS. Classified as Filter, Intravascular, Cardiovascular (product code DTK), Class II - Special Controls.

Submitted by Boston Scientific Corp (Watertown, US). The FDA issued a Cleared decision on November 8, 1990 after a review of 212 days - an extended review 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: 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.

FDA 510(k) Submission Details - K901659

510(k) Number K901659 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1990
Decision Date November 08, 1990
Days to Decision 212 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 125d · This submission: 212d
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 82
Devices cleared under the same product code (DTK) and FDA review panel - the closest regulatory comparables to K901659.
VENA CAVA FILTER SYSTEMS, MODIFICATION
K925679 · B. Braun Vena-Tech · Nov 1992
SIMON NITINOL FILTER, MODIFICATION
K912144 · Nitinol Medical Technologies, Inc. · Oct 1991
VENA CAVA FILTER
K901454 · Vena-Tech, Inc. · May 1991
GREENFIELD VENA CAVA FILTER W/19.5 FR INTRODUCER
K901235 · Boston Scientific Corp · Oct 1990
SIMON NITINOL FILTER
K894703 · Nitinol Medical Technologies, Inc. · Apr 1990
VENA CAVA FILTER
K881604 · Vena-Tech, Inc. · Mar 1989
K901659 · TITANIUM GREENFIELD(R) VENA CAVA FILTER W/HOOKS
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