FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BD PhaSeal Optima Connecting Set (C83-O); BD PhaSeal Optima Spike Set (C180-O)
K Number: K250059
·
Decision Sep 12, 2025
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
40
Applicant Total
134
Review Days
245
Basic Information
- Device Name
- BD PhaSeal Optima Connecting Set (C83-O); BD PhaSeal Optima Spike Set (C180-O)
- K Number
- K250059
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Becton, Dickinson and Company
- Date Received
- January 10, 2025
- Decision Date
- September 12, 2025
- Product Code
- ONB
- 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 |
|---|---|---|---|
| ONB | Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System | FDA class 2 | General Hospital |
Similar 510(k) Clearances
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