| ASTM F2477-07 (Reapproved 2013) Standard Test Methods for in vitro Pulsatile Durability |
| Recognition Date | 2013-08-06 |
| Recognition List | 031 |
| Recognition Number | 3-87 |
| Extent | Complete standard |
| Standards Orgs | ASTM ASTM International http://www.astm.org/ |
| STG | Cardiovascular |
| FDA Tech | Finn Donaldson FDA/OMPT/CDRH/ODE/DCD/PIDB/ 301-796-9579 Finn.Donaldson@fda.hhs.gov |
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These test methods cover the determination of the durability of a vascular stent by exposing it to physiologically relevant diametric distension levels by means of hydrodynamic pulsatile loading. This testing occurs on a stent test specimen that has been deployed into a mock (elastically simulated) vessel. The typical duration of this test is 10 years of equivalent use (at 72 beats per minute), or at least 380 million cycles.
| Regulation Number | Device Name | Device Class | Product Code |
| Unclassified | Intracranial Aneurysm Flow Diverter | Class 3 | OUT |
| Regulation Number | Device Name | Device Class | Product Code |
| Unclassified | Intracranial Neurovascular Stent | Class f | NJE |
| 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. |