K231652
- 510(k) number
- K231652
- Device name
- D100 KIDS; D101 KIDS
- Applicant
- Sorin Group Italia S.R.L. IT
- Product code
- DTZ — Oxygenator, Cardiopulmonary Bypass
- Decision date
- 2023-11-16
- Date received
- 2023-06-06
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.0 MB · U.S. public domain
Also available from FDA: K231652.pdf
Official FDA record: K231652
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.