Peripheral Vascular Atherectomy Devices - Premarket Notification [510(k)] Submissions: Guidance for Industry and Food and Drug Administration Staff

Name: Peripheral Vascular Atherectomy Devices - Premarket Notification [510(k)] Submissions: Guidance for Industry and Food and Drug Administration Staff
Creator: Food and Drug Administration
Keywords: 510k,atherectomy,fda,guidances,industry,notification,peripheral,pre-market,pre-market-notification,submissions,vascular

Information

Type

Guidance

Regulated products

Medical Devices

Topics

Labeling, Premarket

Published

May 20, 2021

Last updated

May 19, 2021

Description

This document provides guidance for industry and FDA staff on premarket notification submissions for peripheral vascular atherectomy devices.

Organization

Food and Drug Administration (FDA) 🇺🇸

Country / Region

United States

License

Other (Public Domain)

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1 Main file

Peripheral Vascular Atherectomy Devices - Premarket Notification [510(k)] Submissions: Guidance for Industry and Food and Drug Administration Staff

Updated on May 19, 2021

pdf (652.1KB)

URL: https://www.fda.gov/media/114852/download
Permalink: https://data.openrid.co/en/datasets/r/6140ab76-2aa8-4892-8493-0032b0853fe8
MIME Type: application/pdf

Created on: May 20, 2021
Modified on: May 19, 2021

Size: 652.1KB

Peripheral Vascular Atherectomy Devices - Premarket Notification [510(k)] Submissions: Guidance for Industry and Food and Drug Administration Staff

Information

Type

Regulated products

Topics

Published

Last updated

Description

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Organization

Country / Region

License

Feedback

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