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Meridian Filter System - Femoral Delivery Kit

FDA 510(k)

Class II (US FDA 510(k))

510(k) K112497

by C. R. Bard, Inc.

Identifiers

510(k) Number
K112497 FDA 510(k)
FDA Product Code
DTK FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.3375 FDA 510(k)
Regulation Number
870.3375 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Meridian Filter System - Femoral Delivery Kit is an intravascular filter device for permanent placement in the inferior vena cava (≤28 mm diameter) to prevent pulmonary embolism. It consists of 12 electropolished shape-memory nitinol wires (6 legs with hooks, 6 arms with anchors) for filtration and fixation.

The kit includes an 8 French introducer sheath and dilator. It is supplied by C. R. Bard, Inc. and has received FDA 510(k) clearance (K112497) as a Class II device under special controls, classified as Filter, Intravascular, Cardiovascular (product code DTK).

Frequently asked questions

What is the Meridian Filter System - Femoral Delivery Kit used for?

It is an intravascular filter device designed for permanent placement in the inferior vena cava with a diameter of 28 mm or less to prevent pulmonary embolism by capturing blood clots before they reach the lungs.

What components are included in the Meridian Filter System - Femoral Delivery Kit?

The kit includes the Meridian filter device composed of 12 electropolished shape-memory nitinol wires (6 legs with hooks and 6 arms with anchors), an 8 French introducer sheath, and a dilator for delivery and deployment.

Is the Meridian Filter System - Femoral Delivery Kit intended for single use or reuse?

The device is intended for single use only, as it is designed for permanent implantation and the delivery components (sheath and dilator) are provided sterile and are not designed for reprocessing or reuse.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Meridian Filter System - Femoral Delivery Kit, MERIDIAN FILTER SYSTEM - FEMORAL DELIVE... (K112497) - FDA 510(k), MERIDIAN FILTER SYSTEM - FEMORAL DELIVERY KIT 510(k) K112497 - fda.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
C. R. Bard, Inc.
FDA Applicant
C.R. Bard, Inc.

Sources (1)

  • FDA 510(k) K112497 24 fields · synced Sep 25, 2026