510(k) K231957
- Device
- SafeBreak® Vascular
- Applicant
- Lineus Medical
- 510(k) number
- K231957
- Product code
- QOI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-09-29
- Date received
- 2023-07-03
- Regulation
- 880.5220
- Classification name
- Intravenous Catheter Force-Activated Separation Device.
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Vance Clement
- Address
- 179 N. Church Ave., Suite 202 Fayetteville AZ US 72701 72701
FDA Registration Numbers#
- 1064858
- 3023851856
- 3017705285
- 3011824610
- 3005977121
- 3019511659
- 3016733629
Source Documents#
Other 510(k) Records For Product Code QOI#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K241415 | Orchid Safety Release Valve™ | Linear Health Sciences, LLC | 2024-09-06 |
| K232094 | Orchid Safety Release ValveTM | Linear Health Sciences, LLC | 2023-10-03 |
| K223486 | SafeBreak® Vascular | Lineus Medical | 2023-05-19 |
| K230266 | Orchid Safety Release Valve | Linear Health Sciences, LLC | 2023-05-04 |
| K222791 | SafeBreak Vascular | Lineus Medical, LLC | 2022-10-16 |
| K212064 | Orchid Safety Release Valve(TM) | Linear Health Sciences, LLC | 2022-05-03 |
| DEN190043 | SafeBreak Vascular | Site Saver, Inc. D/B/A Lineus Medical | 2021-05-27 |