CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX

System, Balloon, Intra-aortic And Control

DATASCOPE CORP.

The following data is part of a premarket notification filed by Datascope Corp. with the FDA for Cs100 Intra-aortic Balloon Pump, Model 0998-00-3013-xx.

Pre-market Notification Details

• Device ID: K031636
• 510k Number: K031636
• Device Name: CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX
• Classification: System, Balloon, Intra-aortic And Control
• Applicant: DATASCOPE CORP. 800 MACARTHUR BLVD. Mahwah, NJ 07430 -0619
• Contact: Susan Mandy
• Correspondent: Susan Mandy; DATASCOPE CORP. 800 MACARTHUR BLVD. Mahwah, NJ 07430 -0619
• Product Code: DSP
• CFR Regulation Number: 870.3535 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-05-27
• Decision Date: 2003-08-11
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10607567107288	K031636	000
10607567107769	K031636	000
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