Recognized standard
22679 First edition 2021-11
FDA recognition 3-192 · ISO · Cardiovascular
Key facts
| Recognition number | 3-192 |
|---|---|
| Designation | 22679 First edition 2021-11 |
| Title | Cardiovascular implants - Transcatheter cardiac occluders |
| Standards developer | International Organization for Standardization |
| Specialty area | Cardiovascular |
| Date of entry | May 29, 2024 |
| Device classes | Class 3 |
| Scope (excerpt) | This document specifies important in vitro tests including functional and durability characteristics of transcatheter cardiac occluders, and their delivery systems and accessories. This document does not specify exact test methods for functional and durability testing, but it offers requirements and… |
At a glance
- None 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: