| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
038
|
Date of Entry 01/27/2015
|
|
FR Recognition Number
|
3-88
|
| ASTM F2514-08 (Reapproved 2014) Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial |
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Scope/Abstract| This guide establishes general requirements and considerations for the development of finite element models used in the evaluation of the performance of a metallic vascular stent design under uniform radial loading. Suggested criteria are provided for evaluating the typical cases of metallic stents under uniform radially oriented and pulsatile loading. Recommended procedures for checking and validating the finite element model(s) are provided as a means to assess the model and analysis results. Finally, the recommended content of an engineering report covering the mechanical simulations is presented. |
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| Extent of Recognition
|
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 |
|
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. |
|
| FDA Technical Contact
|
| Standards Development Organization
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| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
