Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff

Name: Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff
Creator: Food and Drug Administration
Keywords: 510k,catheters,fda,guidances,industry,notification,peripheral,pre-market,pre-market-notification,submissions

Information

Type

Guidance

Regulated products

Medical Devices

Topics

Labeling, Premarket

Published

April 14, 2023

Last updated

April 13, 2023

Description

This document is a guidance for the industry and FDA staff on premarket notification submissions for peripheral PTA and specialty catheters.

Organization

Food and Drug Administration (FDA) 🇺🇸

Country / Region

United States

License

Other (Public Domain)

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Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff

Updated on April 13, 2023

pdf (767.9KB)

URL: https://www.fda.gov/media/134016/download
Permalink: https://data.openrid.co/en/datasets/r/e860579b-ba90-4b71-9268-846385921819
MIME Type: application/pdf

Created on: April 14, 2023
Modified on: April 13, 2023

Size: 767.9KB

Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - 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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Country / Region

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