K251676
- 510(k) number
- K251676
- Device name
- Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S)
- Applicant
- Microtek Medical, LLC IL · US
- Product code
- LHI — Set, I.V. Fluid Transfer
- Decision date
- 2025-09-16
- Date received
- 2025-05-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K251676.pdf
Official FDA record: K251676
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.