DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14)
FDA 510(k) clearance K243264 · decided 2025-04-25
Clearance details
- K-number
- K243264
- Device name
- DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14)
- Applicant
- Sorin Group Italia S.R.L.
- Decision
- Substantially Equivalent
- Date received
- 2024-10-15
- Decision date
- 2025-04-25
- Days to decision
- 192 days
- Clearance type
- Traditional
- Product code
- KDI
- Device class
- 2
- Regulation number
- 876.5860
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mirandola ( Modena), IT
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.