Cleared Traditional

STAINLESS STEEL GREEN VENA CAVA FILT W/12F INTR SY (K912035) - FDA 510(k) Clearance

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

K912035 · Boston Scientific Corp · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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 82
Devices cleared under the same product code (DTK) and FDA review panel - the closest regulatory comparables to K912035.
Option ELITE Vena Cava Filter System (352506070E 352506100E)
K242612 · Argon Medical Devices, Inc. · Sep 2024
VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System
K240578 · B.Braun Medical, Inc. · Jul 2024
ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK)
K241507 · Aln S.A.R.L. · Jun 2024
Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit
K240257 · Bd · Feb 2024
Celect Platinum Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-CELECT-PT)
K233680 · William Cook Europe Aps · Jan 2024
Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Jugular Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach
K211874 · William Cook Europe Aps · Jul 2021