FDA 510(k) Applications Submitted by Datascope Corp.

FDA 510(k) Number Submission Date Device Name Applicant
K960166 01/16/1996 PERCOR STAT-DL 9.5 FR. 34 & 40CC DATASCOPE CORP.
K961509 04/19/1996 INTRA-AORTIC BALLOON PUMP SYSTEM 97 MODIFIED DATASCOPE CORP.
K970061 01/07/1997 ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR (0998-00-0117-XX) DATASCOPE CORP.
K151254 05/12/2015 CARDIOSAVE Hybrid Intra-Aortic Balloon Pump DATASCOPE CORP.
K172305 07/31/2017 CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump Datascope Corp.
K163542 12/16/2016 CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case Datascope Corp.
K181122 04/30/2018 CARDIOSAVE Intra-Aortic Balloon Pump Datascope Corp.
K041281 05/13/2004 DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIES DATASCOPE CORP.
K031569 05/20/2003 DATASCOPE CA 40 8FR. IABS, MODEL 0684-00-04XX DATASCOPE CORP.
K020257 01/24/2002 DATASCOPE'S 8FR. ALT B IAB; DATASCOPE'S PROFILE 8FR. ALT B IAB; DATASCOPE'S TRUE SHEATHLESS DL 9.5 FR. IAB; DATASCOPE'S DATASCOPE CORP.
K001198 04/13/2000 DATASCOPE NITINOL CATHETER GUIDE WIRE (145 CM), DATASCOPE NITINOL CATHETER GUIDE WIRE (175 CM), DATASCOPE NITINOL CATHET DATASCOPE CORP.
K002365 08/03/2000 DATASCOPE REINFORCED PERCUTANEOUS CATHETER INTRODUCER SET DATASCOPE CORP.
K013326 10/05/2001 MODIFICATION TO: DATASCOPE 8FR. POLYIMIDE ALT B IAB, 25CC, 34CC, 40CC, DATASCOPE INSERTION KIT FOR 8 FR, POLYIMIDE ALT B DATASCOPE CORP.
K003598 11/21/2000 DATASCOPE PROFILE 8FR. ALT B IAB, 34CC, DATASCOPE PROFILE 8FR. ALT B IAB, 40CC, MODEL 0684-000319, 0684-00-0320 DATASCOPE CORP.
K002949 09/21/2000 MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 34CC; MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 40CC DATASCOPE CORP.
K071805 07/02/2007 NETGUARD AUTOMATED CLINICIAN ALERT SYSTEM, MODEL 0998-00-1600-XX DATASCOPE CORP.
K062098 07/24/2006 SPECTRUM MONITOR, MODEL 0998-00-1000-XXXXX DATASCOPE CORP.
K062754 09/14/2006 GAS MODULE SE, MODEL 0998-00-0481-02 DATASCOPE CORP.
K964987 12/13/1996 DATASCOPE PERCOR STAT - DL 9.5 FR. 25 AND 40CC INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION AND PERCOR STAT -0 DATASCOPE CORP.
K133074 09/30/2013 MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIES DATASCOPE CORP.
K190884 04/04/2019 TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool Datascope Corp.
K063525 11/22/2006 DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PUMP CONTROL SYSTEM DATASCOPE CORP.
K042016 07/27/2004 DATASCOPE PROGUIDE CHRONIC DIALYSIS CATHETER DATASCOPE CORP.
K020550 02/19/2002 PASSPORT 2 WITH VIEW 12 ECG ANALYSIS MODULE MODEL # 0998-00-0170-XXXX DATASCOPE CORP.
K983575 10/13/1998 ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR, MODEL # 0998-00-0117-XX DATASCOPE CORP.
K974178 11/06/1997 PASSPORT 5L-CE MODEL 0998-00-0131XXX DATASCOPE CORP.
K974903 12/31/1997 GAS MODULE II, MODEL 0998-00-0143 DATASCOPE CORP.
K031636 05/27/2003 CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX DATASCOPE CORP.
K062569 08/31/2006 SAFEGUARD 24 CM PRESSURE ASSISTED DRESSING DATASCOPE CORP.
K011540 05/18/2001 VIEWPOINT CENTRAL MONITORING SYSTEM, MODEL 0998-00-0187-07 DATASCOPE CORP.
K031760 06/06/2003 VIEWPOINT TELEMETRY SYSTEM DATASCOPE CORP.
K031849 06/16/2003 SPECTRUM PATIENT MONITOR, MODEL 0998-00-0500-XXXXX DATASCOPE CORP.
K051897 07/13/2005 TRIO MONITOR DATASCOPE CORP.
K041907 07/15/2004 TRIO MONITOR DATASCOPE CORP.
K032338 07/29/2003 TRIO MONITOR MODEL 0998-00-0600 DATASCOPE CORP.
K993531 10/18/1999 PASSPORT 2 VITAL SIGNS MONITOR, MODEL 0998-00-0170-XX DATASCOPE CORP.
K980385 02/02/1998 DATASCOPE 8FR. CO-LUMEN 34 AND 40CC INTRA-AORTIC BALLOON CATHETERS FOR OPTIONAL SHEATHLESS INSERTION WITH ACCESSORIES DATASCOPE CORP.
K980780 03/02/1998 DATASCOPE PERCOR STAT-DL 9.5 FR. 25, 34 AND 40CC INTRA-AORIC BALLOONS WITH ALTERNATE B MEMBRANE FOR OPTIONAL SHEATHLES DATASCOPE CORP.
K973007 08/13/1997 DATASCOPE'S 10 FR. FLEXISHEATH PERCUTANEOUS INTRODUCER DATASCOPE CORP.
K994157 12/09/1999 DATASCOPE'S 8FR. POLYMIDE 25CC,34CC AND 40CC IAB AND ACCESSORIES, MODELS 0684-00-0327, 06844-00-0328, 0684-00-0329 DATASCOPE CORP.
K965236 12/31/1996 SYSTEM 96 INTRA-AORTIC BALLOON PUMP (IABP) DATASCOPE CORP.


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