Cleared Traditional

K901659 - TITANIUM GREENFIELD VENA CAVA FILTER W/...

K901659 is the FDA 510(k) clearance for TITANIUM GREENFIELD VENA CAVA FILTER W/... by Boston Scientific Corp. It is a Class 2 Cardiovascular device (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.

View all Boston Scientific Corp devices

Submission Details

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.

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 K901659.
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
GREENFIELD VENA CAVA FILTER W/19.5 FR INTRODUCER
K901235 · Boston Scientific Corp · Oct 1990
TITANIUM GREENFIELD VENA CAVA FILTER CARRIER
K874096 · Medi-Tech, Inc. · Nov 1988
TITANIUM PERCUTANEOUS GREENFIELD VENA CAVE FILTER
K870729 · Medi-Tech, Inc. · Apr 1987