510(k) K192368
K192368 is an FDA 510(k) premarket notification submitted by Fresenius Kabi AG for the device "CATSmart". The FDA issued a decision of Substantially Equivalent on September 27, 2019. The device falls under product code CAC (Apparatus, Autotransfusion), a Class II device regulated under 21 CFR 868.5830. Fresenius Kabi AG has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 27, 2019
- Date Received
- August 30, 2019
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apparatus, Autotransfusion
- Device Class
- Class II
- Regulation Number
- 868.5830
- Review Panel
- CV
- Submission Type