Cleared Traditional

K120402 - CRUX VENA CAVA FILTER SYSTEM

K120402 is an FDA 510(k) clearance for CRUX VENA CAVA FILTER SYSTEM, manufactured by Crux Biomedical. The device is a Class 2 Cardiovascular device with product code DTK cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K120402 · Crux Biomedical · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2012
Decision
156d
Days
Class 2
Risk

K120402 is an FDA 510(k) clearance for the CRUX VENA CAVA FILTER SYSTEM. Classified as Filter, Intravascular, Cardiovascular (product code DTK), Class II - Special Controls.

Submitted by Crux Biomedical (Menlo Park, US). The FDA issued a Cleared decision on July 13, 2012 after a review of 156 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.

FDA 510(k) Submission Details - K120402

510(k) Number K120402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2012
Decision Date July 13, 2012
Days to Decision 156 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
31d slower than avg
Panel avg: 125d · This submission: 156d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01120509 Completed Interventional Industry-sponsored

Crux Biomedical Vena Cava Filter Study - United States

Crux Biomedical Evaluation of the Crux Inferior Vena Cava Filter System 2

88
Patients (actual)
17
Sites
Treatment
Purpose
Open label
Masking
Condition studied Pulmonary Embolism
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Robert Mendes, MD
Sponsor Crux Biomedical (industry)
Started 2010-06-01 → Primary completion 2011-06-01 → Completed 2012-01-01
Primary outcome
Clinical Success
Secondary outcome
Retrieval Success
Study completed - no results published. This trial concluded in 2012 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - DTK Filter, Intravascular, Cardiovascular

All 78
Devices cleared under the same product code (DTK) and FDA review panel - the closest regulatory comparables to K120402.
BARD DENALI FILTER SYSTEM- FEMORAL DELIVERY KIT AND JUGULAR DELIVERY KIT
K130366 · C.R. Bard, Inc. · May 2013
CRUX VENA CAVA FILTER SYSTEM
K122585 · Crux Biomedical · Jan 2013
ALN OPTIONAL VANA CAVA FILTER
K113124 · Aln Implants Chirurgicaux · Nov 2012
COOK CELECT PLATINUM VENA CAVA FILTER SET FOR FEMORAL APPROACH COOK CELECT PLATIUM VENA CAVA FILTER SET FOR JUGULAR APPR
K121629 · William Cook Europe Aps · Jul 2012
COOK CELECT AND GUNTHER TULIP VENA CAVA FILTER SETS
K121057 · William Cook Europe Aps · May 2012
CUNTHER TULIP(R) VENA CAVA FILTER SET FOR FEMORAL APPROACH, COOK CELECT(R) VENA CAVA FILTER FOR FEMORAL APPROACH
K112119 · William Cook Europe Aps · Mar 2012
K120402 · CRUX VENA CAVA FILTER SYSTEM
Download PDF FDA Summary Crux Biomedical