Cleared Traditional

VENA CAVA FILTER SYSTEMS, MODIFICATION (K925679) - FDA 510(k) Clearance

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

K925679 · B. Braun Vena-Tech · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1992
Decision
17d
Days
Class 2
Risk

K925679 is an FDA 510(k) clearance for the VENA CAVA FILTER SYSTEMS, MODIFICATION. Classified as Filter, Intravascular, Cardiovascular (product code DTK), Class II - Special Controls.

Submitted by B. Braun Vena-Tech (Evanston, US). The FDA issued a Cleared decision on November 27, 1992 after a review of 17 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all B. Braun Vena-Tech devices

Submission Details

510(k) Number K925679 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 1992
Decision Date November 27, 1992
Days to Decision 17 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 125d · This submission: 17d
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 39
Devices cleared under the same product code (DTK) and FDA review panel - the closest regulatory comparables to K925679.
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
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