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: K160735
• 510k Number: K160735
• Device Name: CATSmart
• Classification: Apparatus, Autotransfusion
• Applicant: FRESENIUS KABI AG ELSE-KRONER-STRASSE 1 Bad Homburg, DE 61352
• Contact: Barry G. Hicks
• Correspondent: Barry G. Hicks; FRESENIUS KABI USA THREE CORPORATE DRIVE Lake Zurich, IL 60047
• Product Code: CAC
• CFR Regulation Number: 868.5830 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-03-17
• Decision Date: 2016-09-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04086000860048	K160735	000
04052682000874	K160735	000
04052682000850	K160735	000
04052682000812	K160735	000
04052682000744	K160735	000
04052682000720	K160735	000