SafeBreak Vascular
FDA 510(k) clearance K222791 · decided 2022-10-16
Clearance details
- K-number
- K222791
- Device name
- SafeBreak Vascular
- Applicant
- Lineus Medical, LLC
- Decision
- Substantially Equivalent
- Date received
- 2022-09-15
- Decision date
- 2022-10-16
- Days to decision
- 31 days
- Clearance type
- Special
- Product code
- QOI
- Device class
- 2
- Regulation number
- 880.5220
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Fayetteville, AZ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Orchid Safety Release Valve™ (K241415) | Linear Health Sciences, LLC | 2024-09-06 |
| Orchid Safety Release ValveTM (K232094) | Linear Health Sciences, LLC | 2023-10-03 |
| SafeBreak® Vascular (K231957) | Lineus Medical | 2023-09-29 |
| SafeBreak® Vascular (K223486) | Lineus Medical | 2023-05-19 |
| Orchid Safety Release Valve (K230266) | Linear Health Sciences, LLC | 2023-05-04 |
| Orchid Safety Release Valve(TM) (K212064) | Linear Health Sciences, LLC | 2022-05-03 |
| SafeBreak Vascular (DEN190043) | Site Saver, Inc. D/B/A Lineus Medical | 2021-05-27 |
Recalls involving this device
No recalls on record reference this clearance.