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Spiration Valve System Deployment Catheter and Loader

by Gyrus Acmi, Inc.

PMA P180007

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

PMA P180007↗

FDA record

Trust

Unverified

Source FDA PMA, synced 6 Oct 2026.

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP180007 Date3 Dec 2018ApprovedStatusActive

Official records

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0551-2022 FDA Class II initiated 23 Dec 2021

    Mislabeled Patient Charge Label indicating model number SVS-V7-00 (7mm) instead of SVS-V9-00 (9mm)

Timeline

2 dated events

  1. Approved FDA PMA P180007
  2. Recall initiated FDA recalls Z-0551-2022

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Trade name
Spiration® Valve System
Generic name
Valve, pulmonary
PMA number
FDA product code
NJK
Device class
Class III
Advisory committee
Anesthesiology
FDA decision
APPR Approved

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

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