CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP

System, Balloon, Intra-aortic And Control

CARDIAC ASSIST, MAQUET CARDIOVASCULAR LLC

The following data is part of a premarket notification filed by Cardiac Assist, Maquet Cardiovascular Llc with the FDA for Cardiosave Hybrid Intra-aortic Balloon Pump.

Pre-market Notification Details

• Device ID: K112372
• 510k Number: K112372
• Device Name: CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP
• Classification: System, Balloon, Intra-aortic And Control
• Applicant: CARDIAC ASSIST, MAQUET CARDIOVASCULAR LLC 1300 MACARTHUR BLVD. Mahwah, NJ 07430
• Contact: Helder A Sousa
• Correspondent: Helder A Sousa; CARDIAC ASSIST, MAQUET CARDIOVASCULAR LLC 1300 MACARTHUR BLVD. Mahwah, NJ 07430
• Product Code: DSP
• CFR Regulation Number: 870.3535 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-08-17
• Decision Date: 2011-09-15
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10607567111995	K112372	000
10607567111964	K112372	000
10607567112312	K112372	000
10607567111971	K112372	000
10607567108407	K112372	000