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Spiration Valve System Deployment Catheter and Loader

FDA PMA

Class III (US FDA PMA)

PMA P180007

by Gyrus Acmi, Inc.

Identity

Trade Name
Spiration® Valve System FDA PMA
Generic Name
Valve, pulmonary FDA PMA

Identifiers

PMA Number
P180007 FDA PMA
FDA Product Code
NJK FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
Anesthesiology FDA PMA
FDA Decision
APPR Approved FDA PMA

The Spiration Valve System Deployment Catheter and Loader is a device used to deploy one-way endobronchial valves. These valves are indicated for adult patients with shortness of breath and hyperinflation associated with severe emphysema in lung regions with low collateral ventilation. The system is intended to be used by a healthcare professional during a bronchoscopic procedure.

The device is supplied sterile and is intended for single use. It is regulated as a Class III medical device and has been authorized by the FDA under a Premarket Approval (PMA) application.

Frequently asked questions

What is the Spiration Valve System Deployment Catheter and Loader used for?

The Spiration Valve System Deployment Catheter and Loader is used to deploy one-way endobronchial valves. These valves are intended for adult patients with severe emphysema who experience shortness of breath and hyperinflation, specifically in lung regions that have low collateral ventilation.

Is the Spiration Valve System Deployment Catheter and Loader a single-use device?

Yes, the Spiration Valve System Deployment Catheter and Loader is intended for single use. It is supplied sterile to ensure the safety and efficacy of the procedure.

What is the regulatory status of the Spiration Valve System Deployment Catheter and Loader?

The Spiration Valve System Deployment Catheter and Loader is a Class III medical device. It has been authorized by the FDA under a Premarket Approval (PMA) application, which is a rigorous process to demonstrate the safety and effectiveness of the device.

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

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Gyrus Acmi, Inc.

Sources (1)

  • FDA PMA P180007 24 fields · synced Sep 18, 2026