Gianturco-Roehm Bird's Nest Vena Cava Filter
FDA PMAFDA 510(k)Class II (US FDA PMA)
by Cook, Inc.
Identity
- Trade Name
- COOK BIRD'S NEST VENA CAVA FILTER FDA PMA
- Generic Name
- FILTER, INTRAVASCULAR, CARDIOVASCULAR FDA PMA
Classification
- Device Class
- Class II FDA PMA
- Legislation / Framework
- 21 CFR Part 870.3375 FDA PMA
- Regulation Number
- 870.3375 FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- SESE Substantially Equivalent FDA PMA
The Gianturco-Roehm Bird’s Nest Vena Cava Filter is an Intravascular, Cardiovascular Filter designed for placement within the inferior vena cava. This retrievable or permanent device is intended to prevent pulmonary embolism by trapping venous thrombi while allowing normal blood flow through its porous, birdcage-like structure.
The filter is supplied sterile and is implanted via catheterisation under fluoroscopic guidance. Available in multiple sizes, it is classified as a Class II medical device under FDA regulations (21 CFR 870.3375) and has received both FDA 510(k) clearance and FDA PMA approval. It is intended for use in vascular procedures and must be handled and stored according to manufacturer instructions to maintain sterility and functionality.
Frequently asked questions
What is the primary purpose of the Gianturco-Roehm Bird’s Nest Vena Cava Filter and how does it function within the body?
The Gianturco-Roehm Bird’s Nest Vena Cava Filter is designed to prevent pulmonary embolism by trapping venous thrombi (blood clots) in the inferior vena cava. Its porous, birdcage-like structure allows normal blood flow to continue while physically capturing clots that could otherwise travel to the lungs. It is retrievable or permanent, meaning it can either be removed later or left in place as needed.
How is the device supplied and what precautions should be taken to ensure sterility during use?
The filter is supplied sterile and intended for implantation via catheterization under fluoroscopic guidance. To maintain sterility and functionality, it must be handled and stored strictly according to the manufacturer’s instructions, as outlined in the accompanying documentation.
What sizes are available for the Gianturco-Roehm Bird’s Nest Vena Cava Filter, and how does this affect its clinical application?
The device is available in multiple sizes, as indicated by the registration numbers (e.g., 3009526575, 1018233, etc.), which correspond to different configurations or diameters. These variations allow clinicians to select the appropriate size based on patient anatomy and procedural requirements, ensuring proper placement and effectiveness in the inferior vena cava.
Is the device intended for single-use only, or can it be reused after retrieval?
The Gianturco-Roehm Bird’s Nest Vena Cava Filter is designed as a retrievable or permanent implant, meaning it is not intended for reuse after initial placement. If retrieval is planned, it must be removed via a separate procedure, and the device should not be reused on another patient.
What regulatory pathway was followed for FDA clearance of this device, and what does that mean for clinicians?
The device received both **FDA 510(k) clearance** (traditional pathway, classified as substantially equivalent) and **FDA PMA approval**, indicating it underwent rigorous review by the Cardiovascular (CV) Advisory Committee. Clinicians can rely on this dual approval as evidence of its safety and effectiveness for preventing pulmonary embolism in the inferior vena cava, though specific use must adhere to the manufacturer’s instructions.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K161218 | Class II | Active |
| FDA PMA | United States | FDA_PMA | P850049 | Class II | Active |
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Manufacturer
- Manufacturer
- Cook, Inc.
- FDA Applicant
- Cook Incorporated
Sources (2)
- FDA PMA P850049 37 fields · synced Sep 18, 2026
- FDA 510(k) K161218 1 fields · synced May 18, 2026