510(k) K223361
K223361 is an FDA 510(k) premarket notification submitted by Sorin Group Italia S.R.L. for the device "BMR 1900 PHISIO". The FDA issued a decision of Substantially Equivalent on June 10, 2023. The device falls under product code DTN (Reservoir, Blood, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4400. Sorin Group Italia S.R.L. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 10, 2023
- Date Received
- November 3, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Reservoir, Blood, Cardiopulmonary Bypass
- Device Class
- Class II
- Regulation Number
- 870.4400
- Review Panel
- CV
- Submission Type