510(k) K251257
- Device
- nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]
- Applicant
- Np Medical
- 510(k) number
- K251257
- Product code
- FPA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-12-04
- Date received
- 2025-04-23
- Regulation
- 880.5440
- Classification name
- Set, Administration, Intravascular
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Albert Sanford
- Address
- 101 Union St. Clinton MA US 01510 01510
FDA Registration Numbers
- 1450662
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Source Documents
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