Cleared Traditional

K240578 - VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence.

K240578 · B.Braun Medical, Inc. · Cardiovascular device
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Jul 2024
Decision
152d
Days
Class 2
Risk

K240578 is an FDA 510(k) clearance for the VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filt.... Classified as Filter, Intravascular, Cardiovascular (product code DTK), Class II - Special Controls.

Submitted by B.Braun Medical, Inc. (Center Valley, US). The FDA issued a Cleared decision on July 31, 2024 after a review of 152 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.

View all B.Braun Medical, Inc. devices

Submission Details

510(k) Number K240578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2024
Decision Date July 31, 2024
Days to Decision 152 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
27d slower than avg
Panel avg: 125d · This submission: 152d
Pathway characteristics
Predicate-based equivalence.

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. 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
NCT02381509 Completed Observational

Predicting the Safety and Effectiveness of Inferior Vena Cava Filters

1428
Patients (actual)
53
Sites
Condition studied Pulmonary Embolism; Deep Vein Thrombosis
Eligibility All sexes · 18 Years+
Principal investigator David L. Gillespie, MD, FACS
Sponsor Carelon Research
Started 2015-10-01 → Primary completion 2020-03-17 → Completed 2021-09-20
Primary outcome
Composite safety endpoint of freedom from clinically significant perforation after successful filter placement, filter embolization, caval thrombotic occlusion, deep vein thrombosis, and perioperative serious adverse event
Secondary outcome
Mechanical Stability
Study completed - no results published. This trial concluded in 2021 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 82
Devices cleared under the same product code (DTK) and FDA review panel - the closest regulatory comparables to K240578.
Option ELITE Vena Cava Filter System (352506070E 352506100E)
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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)
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