Submission Details
| 510(k) Number | K210089 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 13, 2021 |
| Decision Date | February 11, 2021 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
CATSmart, Automated Blood Processing Autotransfusion System
Feb 2021
Decision
29d
Days
Class 2
Risk
About This 510(k) Submission
K210089 is an FDA 510(k) clearance for the CATSmart, Automated Blood Processing Autotransfusion System, a Apparatus, Autotransfusion (Class II — Special Controls, product code CAC), submitted by Fresenius Kabi AG (Bad Homburg, DE). The FDA issued a Cleared decision on February 11, 2021, 29 days after receiving the submission on January 13, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 868.5830.
Device Classification
| Product Code | CAC — Apparatus, Autotransfusion |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 868.5830 |
Manufacturer
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