510(k) K011838
K011838 is an FDA 510(k) premarket notification submitted by Stockert Instrumente GmbH for the device "CENTRIFUGAL PUMP". The FDA issued a decision of Substantially Equivalent on February 5, 2002. The device falls under product code DWA (Control, Pump Speed, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4380. Stockert Instrumente GmbH has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 5, 2002
- Date Received
- June 12, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Control, Pump Speed, Cardiopulmonary Bypass
- Device Class
- Class II
- Regulation Number
- 870.4380
- Review Panel
- CV
- Submission Type