ROTA FLOW CENTRIFUGAL PUMP WITH BIOLINE COATING, MODELS BE-RF-32, BEQ-RF-32

Pump, Blood, Cardiopulmonary Bypass, Non-roller Type

MAQUET CARDIOPULMONARY AG

The following data is part of a premarket notification filed by Maquet Cardiopulmonary Ag with the FDA for Rota Flow Centrifugal Pump With Bioline Coating, Models Be-rf-32, Beq-rf-32.

Pre-market Notification Details

• Device ID: K080470
• 510k Number: K080470
• Device Name: ROTA FLOW CENTRIFUGAL PUMP WITH BIOLINE COATING, MODELS BE-RF-32, BEQ-RF-32
• Classification: Pump, Blood, Cardiopulmonary Bypass, Non-roller Type
• Applicant: MAQUET CARDIOPULMONARY AG HECHINGER STRASSE 38 Hirrlingen, DE 72145
• Contact: Katrin Schwekglenks
• Correspondent: Katrin Schwekglenks; MAQUET CARDIOPULMONARY AG HECHINGER STRASSE 38 Hirrlingen, DE 72145
• Product Code: KFM
• CFR Regulation Number: 870.4360 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-02-21
• Decision Date: 2008-09-12
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04037691530871	K080470	000