Recognized standard
F2394-07 (Reapproved 2017)
FDA recognition 3-86 · ASTM · Cardiovascular
Key facts
| Recognition number | 3-86 |
|---|---|
| Designation | F2394-07 (Reapproved 2017) |
| Title | Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System |
| Standards developer | ASTM International |
| Specialty area | Cardiovascular |
| Date of entry | Jan 14, 2019 |
| Device classes | Class 3 |
| Scope (excerpt) | This guide provides guidance for the design and development of pre-test treatments, tests, and test endpoints to measure stent securement of pre-mounted, unsheathed, balloon-expandable stent delivery systems. This guide is intended to aid investigators in the design, development, and in vitro… |
At a glance
- 1–9 Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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: