Cleared Traditional

VENA TECH VENA CAVA FILTER (K010485) - FDA 510(k) Clearance

Also marketed or referenced as:
VENA TECH 30D VENA CAVA FILTER VENA TECH LP CAVE FILTER

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

K010485 · Bbraun · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
87d
Days
Class 2
Risk

K010485 is an FDA 510(k) clearance for the VENA TECH VENA CAVA FILTER. Classified as Filter, Intravascular, Cardiovascular (product code DTK), Class II - Special Controls.

Submitted by Bbraun (Evanston, US). The FDA issued a Cleared decision on May 18, 2001 after a review of 87 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 Bbraun devices

Submission Details

510(k) Number K010485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2001
Decision Date May 18, 2001
Days to Decision 87 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
38d faster than avg
Panel avg: 125d · This submission: 87d
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 38
Devices cleared under the same product code (DTK) and FDA review panel - the closest regulatory comparables to K010485.
RECOVERY FILTER SYSTEM, MODEL RF-048F
K022236 · C.R. Bard, Inc. · Nov 2002
CORDIS OPTEASE PERMANENT VENA CAVA FILTER, MODELS 466-F200A, 466-F200B
K023116 · Cordis Corp. · Oct 2002
TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT, MODEL 466-P306A
K010083 · Cordis Corp. · Jun 2001
TRAPEASE PERMANENT VENA FILTER AND INTRODUCTION KIT, MODELS 466-P306A AND 466-P306B
K003964 · Cordis Corp. · Jan 2001
GUNTHER TULIP VENA CAVA MREYE FILTER SET
K000855 · Cook, Inc. · Oct 2000
CORDIS TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT
K000062 · Cordis Corp. · Jul 2000