Recognized standard
10555-4 Third edition 2023-11
FDA recognition 6-498 · ISO · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-498 |
|---|---|
| Designation | 10555-4 Third edition 2023-11 |
| 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 | May 29, 2024 |
| Device classes | Class 2 |
| Scope (excerpt) | This document specifies requirements for balloon dilatation catheters supplied sterile and intended for single use. This document does not specify requirements for vascular stents (see ISO 25539-2). |
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: