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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 051 Date of Entry 01/14/2019 
FR Recognition Number 3-79
Standard
ASTM  F2079-09 (Reapproved 2017)
Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents
Scope/Abstract
The purpose of this test method is to quantify the percentage by which the diameter of a stent decreases from its expanded diameter while still on the delivery balloon to its relaxed diameter after deflating the balloon. This test method is appropriate for stents manufactured from a material that is plastically deformed when the stent's diameter is increased from its predeployed to its postdeployed by mechanical means. This test method may be performed in air at room temperature unless there is a known temperature dependence of the material, in which case, the temperature at which the test is conducted shall be stated in the report.
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
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*
Guidance for Industry and FDA Staff: Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems, Issued April 2010.

Guidance for Industry Coronary Drug-Eluting Stents: Nonclinical and Clinical Studies, Issued March 2008.

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 Contact
 Jhumur Banik
  FDA/OC/CDRH/OPEQ/OHTII/DHTIIC/
  240-402-5239
  Jhumur.Banik@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Cardiovascular
*These are provided as examples and others may be applicable.
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