FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Orchid Safety Release ValveTM
K Number: K232094
·
Decision Oct 3, 2023
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
7
Applicant Total
4
Review Days
82
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Basic Information
- Device Name
- Orchid Safety Release ValveTM
- K Number
- K232094
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5220
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Linear Health Sciences, LLC
- Date Received
- July 13, 2023
- Decision Date
- October 3, 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 |
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