510(k) K200091
K200091 is an FDA 510(k) premarket notification submitted by Terumo Cardiovascular Systems Corporation for the device "Capiox iCP Centrifugal Pump". The FDA issued a decision of Substantially Equivalent on November 18, 2021. The device falls under product code KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type), a Class II device regulated under 21 CFR 870.4360. Terumo Cardiovascular Systems Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 18, 2021
- Date Received
- January 16, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
- Device Class
- Class II
- Regulation Number
- 870.4360
- Review Panel
- CV
- Submission Type