Recognized standard
F2079-09 (Reapproved 2017)
FDA recognition 3-79 · ASTM · Cardiovascular
Key facts
| Recognition number | 3-79 |
|---|---|
| Designation | F2079-09 (Reapproved 2017) |
| Title | Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents |
| Standards developer | ASTM International |
| Specialty area | Cardiovascular |
| Date of entry | Jan 14, 2019 |
| Device classes | Class 3 |
| Scope (excerpt) | 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… |
At a glance
- None Product codes
- 1–9 FDA guidance documents
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About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: