Recognized standard
5910 First edition 2018-06
FDA recognition 3-159 · ISO · Cardiovascular
Key facts
| Recognition number | 3-159 |
|---|---|
| Designation | 5910 First edition 2018-06 |
| Title | Cardiovascular implants and extracorporeal systems - Cardiac valve repair devices |
| Standards developer | International Organization for Standardization |
| Specialty area | Cardiovascular |
| Date of entry | Jan 14, 2019 |
| Device classes | Class 3 |
| Scope (excerpt) | 1.1 This document applies to all heart valve repair systems that have an intended use to repair and/or improve the function of native human heart valves by acting either on the valve apparatus or on the adjacent anatomy (e.g. ventricle, coronary sinus). 1.2 This document outlines an approach for… |
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: