Cleared Traditional

K912035 - STAINLESS STEEL GREEN VENA CAVA FILT W/...

K912035 is the FDA 510(k) clearance for STAINLESS STEEL GREEN VENA CAVA FILT W/... by Boston Scientific Corp. It is a Class 2 Cardiovascular device (product code DTK) cleared through the Traditional 510(k) pathway after a 1498-day FDA review.

K912035 · Boston Scientific Corp · Cardiovascular device
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Jun 1995
Decision
1498d
Days
Class 2
Risk

K912035 is an FDA 510(k) clearance for the STAINLESS STEEL GREEN VENA CAVA FILT W/12F INTR SY. 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 June 15, 1995 after a review of 1498 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Boston Scientific Corp devices

Submission Details

510(k) Number K912035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1991
Decision Date June 15, 1995
Days to Decision 1498 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
1373d slower than avg
Panel avg: 125d · This submission: 1498d
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 K912035.
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
TITANIUM GREENFIELD(R) VENA CAVA FILTER W/HOOKS
K901659 · Boston Scientific Corp · Nov 1990
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