FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SafeBreak® Vascular
K Number: K223486
·
Decision May 19, 2023
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
7
Applicant Total
2
Review Days
179
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Basic Information
- Device Name
- SafeBreak® Vascular
- K Number
- K223486
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5220
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lineus Medical
- Date Received
- November 21, 2022
- Decision Date
- May 19, 2023
- Product Code
- QOI
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QOI | Intravenous Catheter Force-Activated Separation Device. | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QOI), ordered by most recent decision date.
Orchid Safety Release Valve
FDA 510(k)
FDA Class 2
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Orchid Safety Release ValveTM
FDA 510(k)
FDA Class 2
·General Hospital
SafeBreak® Vascular
FDA 510(k)
FDA Class 2
·General Hospital
Orchid Safety Release Valve
FDA 510(k)
FDA Class 2
·General Hospital
SafeBreak Vascular
FDA 510(k)
FDA Class 2
·General Hospital
Orchid Safety Release Valve(TM)
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Lineus Medical
| K Number | Device Name | ||
|---|---|---|---|
| K231957 | SafeBreak® Vascular | Sep 29, 2023 | Substantially Equivalent |