510(k) K080832
K080832 is an FDA 510(k) premarket notification submitted by Sorin Group Deutschland GmbH for the device "STOCKERT S5 SYSTEM, STOCKERT GAS BLENDER". The FDA issued a decision of Substantially Equivalent on July 30, 2008. The device falls under product code DTQ (Console, Heart-Lung Machine, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4220. Sorin Group Deutschland GmbH has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 30, 2008
- Date Received
- March 25, 2008
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Console, Heart-Lung Machine, Cardiopulmonary Bypass
- Device Class
- Class II
- Regulation Number
- 870.4220
- Review Panel
- CV
- Submission Type