CATSmart

Apparatus, Autotransfusion

Fresenius Kabi AG

The following data is part of a premarket notification filed by Fresenius Kabi Ag with the FDA for Catsmart.

Pre-market Notification Details

• Device ID: K192368
• 510k Number: K192368
• Device Name: CATSmart
• Classification: Apparatus, Autotransfusion
• Applicant: Fresenius Kabi AG Else-Kroner-Strasse 1 Bad Homburg, DE 61352
• Contact: Shane Sawall
• Correspondent: Shane Sawall; Fresenius Kabi Three Corporate Drive Lake Zurich, IL 60047
• Product Code: CAC
• CFR Regulation Number: 868.5830 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-08-30
• Decision Date: 2019-09-27
• Summary: summary