Recognized standard
10555-4 Second edition 2013-06-15
FDA recognition 6-322 · ISO · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-322 |
|---|---|
| Designation | 10555-4 Second edition 2013-06-15 |
| Title | Intravascular catheters -- Sterile and single-use catheters -- Part 4: Balloon dilatation catheters |
| Standards developer | International Organization for Standardization |
| Specialty area | General Plastic Surgery/General Hospital |
| Date of entry | Jan 30, 2014 |
| Device classes | Class 2 |
| Scope (excerpt) | ISO 10555-4:2013 specifies requirements for balloon dilatation catheters supplied in the sterile condition, and intended for single use. |
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: