Search FDA 510(k) Database

Cleared Dec 26, 2019

TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool

K190884 · GDW

Datascope Corp.

General & Plastic Surgery · 266d

Cleared May 31, 2018

CARDIOSAVE Intra-Aortic Balloon Pump

K181122 · DSP

Datascope Corp.

Cardiovascular · 31d

Cleared Oct 12, 2017

CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump

K172305 · DSP

Datascope Corp.

Cardiovascular · 73d

Cleared Jan 31, 2017

CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion...

K163542 · DSP

Datascope Corp.

Cardiovascular · 46d

Cleared Jul 02, 2015

CARDIOSAVE Hybrid Intra-Aortic Balloon Pump

K151254 · DSP

Datascope Corp.

Cardiovascular · 51d

Cleared Dec 12, 2013

MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS...

K133074 · DSP

Datascope Corp.

Cardiovascular · 73d

Cleared Feb 14, 2013

A5 ANESTHESIA DELIVERY SYSTEM

K123211 · BSZ

Datascope Corp., Patient Monitoring...

Anesthesiology · 125d

Cleared Nov 09, 2012

AIR-BAND RADIAL COMPRESSION DEVICE

K122405 · DXC

Datascope Corp., Cardiac Assist Division

Cardiovascular · 94d

Cleared Sep 06, 2012

SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHETER AND ACCESSORIES

K122628 · DSP

Datascope Corp., Cardiac Assist Division

Cardiovascular · 9d

Cleared Apr 20, 2012

MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM)...

K120868 · DSP

Datascope Corp., Cardiac Assist Division

Cardiovascular · 29d

Cleared Jul 15, 2009

PASSPORT V MONITOR, MODEL 0998-00-6100

K091834 · MHX

Datascope Corp., Patient Monitoring...

Cardiovascular · 23d

Cleared Jun 18, 2009

DATASCOPE'S 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MODELS...

K091449 · DSP

Datascope Corp., Cardiac Assist Division

Cardiovascular · 31d

Cleared May 08, 2009

ACCUTORR V MONITOR, MODEL 0998-00-2000

K091068 · DXN

Datascope Corp., Patient Monitoring...

Cardiovascular · 24d

Cleared Jun 09, 2008

NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01

K080175 · BSZ

Datascope Corp., Patient Monitoring...

Anesthesiology · 137d

Cleared Sep 25, 2007

NETGUARD AUTOMATED CLINICIAN ALERT SYSTEM, MODEL 0998-00-1600-XX

K071805 · DSI

Datascope Corp.

Cardiovascular · 85d

Cleared Feb 14, 2007

SAFEGUARD 24 CM PRESSURE ASSISTED DRESSING

K062569 · DXC

Datascope Corp.

Cardiovascular · 167d

Cleared Feb 05, 2007

SPECTRUM MONITOR, MODEL 0998-00-1000-XXXXX

K062098 · MHX

Datascope Corp.

Cardiovascular · 196d

Cleared Jan 05, 2007

DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300...

K063525 · DSP

Datascope Corp.

Cardiovascular · 44d

Cleared Nov 02, 2006

GAS MODULE SE, MODEL 0998-00-0481-02

K062754 · BZK

Datascope Corp.

Anesthesiology · 49d

Cleared Aug 12, 2005

TRIO MONITOR

K051897 · MWI

Datascope Corp.

Cardiovascular · 30d

Cleared Sep 23, 2004

DATASCOPE PROGUIDE CHRONIC DIALYSIS CATHETER

K042016 · MSD

Datascope Corp.

Gastroenterology & Urology · 58d

Cleared Jul 23, 2004

TRIO MONITOR

K041907 · MWI

Datascope Corp.

Cardiovascular · 8d

Cleared Jun 07, 2004

DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIES

K041281 · DSP

Datascope Corp.

Cardiovascular · 25d

Cleared Feb 11, 2004

TRIO MONITOR MODEL 0998-00-0600

K032338 · MWI

Datascope Corp.

Cardiovascular · 197d