Cleared Traditional

K901235 - GREENFIELD VENA CAVA FILTER W/19.5 FR INTRODUCER

K901235 is an FDA 510(k) clearance for GREENFIELD VENA CAVA FILTER W/19.5 FR I..., 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 209-day FDA review.

K901235 · Boston Scientific Corp · Cardiovascular device
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Oct 1990
Decision
209d
Days
Class 2
Risk

K901235 is an FDA 510(k) clearance for the GREENFIELD VENA CAVA FILTER W/19.5 FR INTRODUCER. 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 October 9, 1990 after a review of 209 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

FDA 510(k) Submission Details - K901235

510(k) Number K901235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1990
Decision Date October 09, 1990
Days to Decision 209 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
84d slower than avg
Panel avg: 125d · This submission: 209d
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 K901235.
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
TITANIUM GREENFIELD(R) VENA CAVA FILTER W/HOOKS
K901659 · Boston Scientific Corp · Nov 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
PERCUTANEOUS GREENFIELD VENA CAVA FILTER SYSTEM
K852097 · Medi-Tech, Inc. · Nov 1985