FDA Product Code
FDA Product Code QOI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.5220
510(k) Clearances — 8 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K241415 | Orchid Safety Release Valve | Linear Health Sciences, LLC | 2024-09-06 | Traditional | PDF ↗ |
| K232094 | Orchid Safety Release ValveTM | Linear Health Sciences, LLC | 2023-10-03 | Traditional | PDF ↗ |
| K231957 | SafeBreak® Vascular | Lineus Medical | 2023-09-29 | Traditional | PDF ↗ |
| K223486 | SafeBreak® Vascular | Lineus Medical | 2023-05-19 | Traditional | PDF ↗ |
| K230266 | Orchid Safety Release Valve | Linear Health Sciences, LLC | 2023-05-04 | Traditional | PDF ↗ |
| K222791 | SafeBreak Vascular | Lineus Medical, LLC | 2022-10-16 | Special | PDF ↗ |
| K212064 | Orchid Safety Release Valve(TM) | Linear Health Sciences, LLC | 2022-05-03 | Traditional | PDF ↗ |
| DEN190043 | SafeBreak Vascular | Site Saver, Inc. D/B/A Lineus Medical | 2021-05-27 | Direct | — |
Product code QOI · Class II · General Hospital. Data: openFDA.