FDA-recognized standard · Cardiovascular
ASTM F2394: Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System
Yes. FDA recognizes ASTM F2394-07 (Reapproved 2017) as recognition 3-86, in part, entered 2019-01-14.
Recognized editions of ASTM F2394
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 3-86 | ASTM F2394-07 (Reapproved 2017) | 2019-01-14 | Partial | — |
What FDA does not recognize in ASTM F2394-07 (Reapproved 2017)
Recognition 3-86 is partial. FDA's statement of the extent, verbatim:
Partial recognition. The following part(s) of the standard is (are) not recognized: Figure 2.2 Bottom Plate of the Test Tracking Fixture for Conditioning the Stent, Balloon, and Stent Securement System Figure 2.3 Top Plate of the Test Tracking Fixture for Conditioning the Stent, Balloon, and Stent Securement System Figure 2.4 Alternative Test Tracking Fixture
Product codes that cite ASTM F2394
6 FDA product codes cite ASTM F2394, including MAF, NIM, NIN, NIO, NIP.
- MAF
- NIM
- NIN
- NIO
- NIP
- NIQ
Source: FDA Recognized Consensus Standards database, snapshot of 2026-09-01. Search every recognition in the Consensus Standards Lookup, or browse all standards with a page.