510(k) K140012
K140012 is an FDA 510(k) premarket notification submitted by Sorin Group Deutschland GmbH for the device "SORIN FLEXTHERM". The FDA issued a decision of Substantially Equivalent on January 31, 2014. The device falls under product code DWC (Controller, Temperature, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4250. Sorin Group Deutschland GmbH has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 31, 2014
- Date Received
- January 2, 2014
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Controller, Temperature, Cardiopulmonary Bypass
- Device Class
- Class II
- Regulation Number
- 870.4250
- Review Panel
- CV
- Submission Type
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).