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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 051 Date of Recognition 01/14/2019 
FR Recognition Number 3-138
Standard
ASTM F2942-13
Standard Guide for the In Vitro Axial, Bending, and Rotational Durability Test of Vascular Stents
Scope/Abstract
This guide includes three separate cyclic deformation durability guides related to vascular stents: bending, axial, and torsional.This guide does not address flat plate, local crush durability, or multi-mode testing.
Extent of Recognition
Complete standard
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
Unclassified Coronary Drug-Eluting Stent Class 3 NIQ
Unclassified Stent, Carotid Class 3 NIM
Unclassified Stent, Coronary Class 3 MAF
Unclassified Stent, Iliac Class 3 NIO
Unclassified Stent, Renal Class 3 NIN
Unclassified Stent, Superficial Femoral Artery Class 3 NIP
Unclassified System, Endovascular Graft, Aortic Aneurysm Treatment Class 3 MIH
Unclassified System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Class 3 PFV
Relevant FDA Guidance and/or Supportive Publications
Guidance for Industry Coronary Drug-Eluting Stents¿ Nonclinical and Clinical Studies, Issued March 2008.

Guidance for Industry and FDA Staff: Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems, Issued April 2010.


FDA Technical Contact
 Finn Donaldson
  FDA/OMPT/CDRH/ODE/DCD/PIDB/
  301-796-9579
  Finn.Donaldson@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Cardiovascular
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