510(k) K231652
K231652 is an FDA 510(k) premarket notification submitted by Sorin Group Italia S.R.L. for the device "D100 KIDS; D101 KIDS". The FDA issued a decision of Substantially Equivalent on November 16, 2023. The device falls under product code DTZ (Oxygenator, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4350. Sorin Group Italia S.R.L. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 16, 2023
- Date Received
- June 6, 2023
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Oxygenator, Cardiopulmonary Bypass
- Device Class
- Class II
- Regulation Number
- 870.4350
- Review Panel
- CV
- Submission Type