Recognized standard
F623-19
FDA recognition 9-132 · ASTM · ObGyn/Gastroenterology/Urology
Key facts
| Recognition number | 9-132 |
|---|---|
| Designation | F623-19 |
| Title | Standard Performance Specification for Foley Catheter |
| Standards developer | ASTM International |
| Specialty area | ObGyn/Gastroenterology/Urology |
| Date of entry | Jun 7, 2021 |
| Device classes | Class 1, Class 2 |
| Scope (excerpt) | This performance specification establishes performance requirements for the short-term utilization of a single-use, balloon-retention catheter, French s 12 through 26 inclusive, used by the medical professions for providing a means of bladder drainage by means of the urethra. The product is… |
At a glance
- 10–99 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: