| ASTM F2079-09 (Reapproved 2017) Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents |
| Recognition Number | Cardiovascular |
| Recognition Date | 2019-01-14 |
| Recognition List | 051 |
| Recognition Number | 3-79 |
| Extent | Complete standard |
| Standards Orgs | ASTM ASTM International http://www.astm.org/ |
| STG | Cardiovascular |
| FDA Tech | Jhumur Banik FDA/OMPT/CDRH/ODE/DCD/PIDB/ 240-402-5239 Jhumur.Banik@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
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.
| 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 |
| 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. |