# Aurora XI Plasmapheresis System/Aurora XI System/Aurora XI - 1.2 (BK180268)

_Fresenius Kabi AG · Nov 2, 2018 · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/BK180268

## Device Facts

- **Applicant:** Fresenius Kabi AG
- **Decision Date:** Nov 2, 2018
- **Decision:** SESE

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**Source:** [https://fda-staging.innolitics.com/device/BK180268](https://fda-staging.innolitics.com/device/BK180268)

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