| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
057
|
Date of Entry 12/20/2021
|
|
FR Recognition Number
|
3-178
|
| Standard | |
ASTM F3067-14 (Reapproved 2021)
Standard Guide for Radial Loading of Balloon-Expandable and Self-Expanding Vascular Stents |
|
Scope/Abstract| 1.1 This document provides guidance for developing in vitro test methods for measuring the radial strength or collapse pressure of balloon-expandable vascular stents and chronic outward force of self-expanding vascular stents.... |
|
| Extent of Recognition
|
Rationale for Recognition
| This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. |
|
Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| N/A |
Stent, Coronary |
Class 3
|
MAF
|
| N/A |
Stent, Carotid |
Class 3
|
NIM
|
| N/A |
Stent, Renal |
Class 3
|
NIN
|
| N/A |
Stent, Iliac |
Class 3
|
NIO
|
| N/A |
Stent, Superficial Femoral Artery |
Class 3
|
NIP
|
| N/A |
Coronary Drug-Eluting Stent |
Class 3
|
NIQ
|
|
Relevant FDA Guidance and/or Supportive Publications*
1. Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems, Guidance for Industry and Food and Drug Administration Staff, Issued August 2015.
2. Guidance for Industry and FDA Staff: Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems, Issued April 2010.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
|
| FDA Technical Contacts
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
