Coronary and Carotid Embolic Protection Devices - Premarket Notification [510(k)] Submissions : Guidance for Industry and FDA Staff

Name: Coronary and Carotid Embolic Protection Devices - Premarket Notification [510(k)] Submissions : Guidance for Industry and FDA Staff
Creator: Food and Drug Administration
Keywords: 510k,fda,guidances,industry,notification,pre-market,pre-market-notification,protection,submissions

Information

Type

Guidance

Regulated products

Medical Devices

Topics

Premarket

Published

February 15, 2008

Last updated

March 20, 2020

Description

This document provides guidance for industry and FDA staff on premarket notification submissions for coronary and carotid embolic protection devices.

Organization

Food and Drug Administration (FDA) 🇺🇸

Country / Region

United States

License

Other (Public Domain)

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Coronary and Carotid Embolic Protection Devices - Premarket Notification [510(k)] Submissions : Guidance for Industry and FDA Staff

Updated on March 20, 2020

pdf (155.3KB)

URL: https://www.fda.gov/media/71061/download
Permalink: https://data.openrid.co/en/datasets/r/bc11c216-3284-4451-886b-26fa047d8c86
MIME Type: application/pdf

Created on: February 15, 2008
Modified on: March 20, 2020

Size: 155.3KB

Coronary and Carotid Embolic Protection Devices - Premarket Notification [510(k)] Submissions : Guidance for Industry and FDA Staff

Information

Type

Regulated products

Topics

Published

Last updated

Description

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Country / Region

License

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