DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PUMP CONTROL SYSTEM

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 Datascope Fiber Optic Pressure Sensor Intra-aortic Balloon Catheter And Cs300 Intra-aortic Balloon Pump Control System.

Pre-market Notification Details

• Device ID: K063525
• 510k Number: K063525
• Device Name: DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PUMP CONTROL SYSTEM
• Classification: System, Balloon, Intra-aortic And Control
• Applicant: DATASCOPE CORP. 15 LAW DR. Fairfield, NJ 07004 -0011
• Contact: Nancy Cohen
• Correspondent: Nancy Cohen; DATASCOPE CORP. 15 LAW DR. Fairfield, NJ 07004 -0011
• Product Code: DSP
• CFR Regulation Number: 870.3535 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-11-22
• Decision Date: 2007-01-05
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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