FDA.reportPublic FDA data

Datascope Corp.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
22481461000222374Datascope Corp.1N2026-01-0115 Law Dr Unit #1 FAIRFIELD NJ US 07004
22497233001418283Datascope Corp.1N2026-01-011300 Macarthur Blvd MAHWAH NJ US 07430
30079654893007965489Datascope Corp1N2026-01-0145 Barbour Pond Drive Wayne NJ US 07470
30079654893007965489Datascope Corp1N2020-04-2545 Barbour Pond Drive Wayne NJ US 07470

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
10607567106656Reinforced Introducer Set for Linear 7.5Fr & Mega 7.5Fr - 0684-00-0403-05888-627-8383customer.support@maquet.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
63241393262178K943896GUIDE WIRE FOR THE USE WITH DATASCOPE PERCOR STAT-DL IABSDQX1995-12-22
63281277017259K181122CARDIOSAVE Intra-Aortic Balloon PumpDSP2018-05-31
2358081334320198K181122CARDIOSAVE Intra-Aortic Balloon PumpDSP2018-05-31
63281077254805K172305CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon PumpDSP2017-10-12
63281556496396K163542CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage CaseDSP2017-01-31
63281600453458K151254CARDIOSAVE Hybrid Intra-Aortic Balloon PumpDSP2015-07-02
63241218239970K133074MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIESDSP2013-12-12
63241706474550K122628SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHETER AND ACCESSORIESDSP2012-09-06
63241566418512K120868MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETERDSP2012-04-20
63281435243015K112372CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMPDSP2011-09-15
63241369133563K090533HLM TUBING SET WITH SOFTLINE COATINGDWF2009-12-18
63241307668928K083794MECC SET WITH BIOLINE COATINGKFM2009-04-21
63241034855614K080592HLM TUBING SET WITH BIOLINE COATINGDWE2008-09-11
63281184930713K063525DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PUMP CONTROL SYSTEMDSP2007-01-05
63241184930713K063525DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PUMP CONTROL SYSTEMDSP2007-01-05
63241604720083K053025JOSTRA HLM TUBING SETDWE2005-11-10
63241340790937K041281DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIESDSP2004-06-07
63281851424019K031636CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XXDSP2003-08-11
63241097461489K002365DATASCOPE REINFORCED PERCUTANEOUS CATHETER INTRODUCER SETDYB2000-08-25
2820551077254805
2820551184930713
2820551218239970
2820551277017259
2820551340790937
2820551435243015
2820551556496396
2820551566418512
2820551600453458
2820551706474550
63241768718366

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DSP132018-05-31
DWE22008-09-11
DYB22000-08-25
DQX21995-12-22
DWF12009-12-18
KFM12009-04-21

PMA#

PMN#

143 records. Showing 1-40. Next

GUDID#

200 records. Showing 1-40. Next