FDA.reportPublic FDA data

OSCOR CARIBE LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30047852733004785273OSCOR CARIBE LLC1N2026-01-01ZONA FRANCA LAS AMERICAS NAVE A1-2 SANTO DOMINGO Distrito Nacional DO --

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
235632026175434K925168MISCELLANEOUS PACING LEADDTD1994-05-03
235631837998472K884866TEMP. PACING LEADS W/DEPTH MARKINGS TA-1 AND TB-1LDF1989-03-22
235631027795786K872972TEMPORARY PACEMAKER ELECTRODELDF1987-12-03
235631044484743K861403TB SERIES BIPOLAR PACING LEADSLDF1986-06-27
235631050135649K850622OSCOR MEDICAL MODEL TME 64S BIPOLAR TEMP/HEART WIRLDF1985-04-10
235631723645182K831695TEMP. CARDIAC PACING WIRE TME 60/61/65LDF1983-10-20
235631445382572K782018LEADS, IMPLANTABLE CARDIAC PACEMAKERSDTB1979-06-04
235631240148562K140917INTRODUCER, MODEL ADELANTE MAGNUMDYB2014-07-09
235631069013562K140406DESTINO TWIST, STEERABLE GUIDING SHEATHDYB2014-04-17
235631384332130K130843SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIREDRC2014-01-08
235631392411599K130633INTRODUCER SETS, MODEL ADELANTE RADIALDYB2014-02-13
235631956006568K122960STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINODYB2012-12-13
235631690085602K122958DELIVERY SHEATH, MODEL ADELANTE BREEZEWAYDYB2012-12-13
235631043973770K122084INTRODUCER SET, MODEL ADELANTE-S SERIESDYB2012-08-29
235631246599471K120459STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINODYB2012-06-29
235631667071760K101497DELIVERY SHEATH, MODEL ADELANTE BREEZEWAYDYB2010-10-20
235631695098864K092118ANGIOGRAPHIC CATHETER, MODEL ANGIOSDQO2010-01-13
235631288579789K090114MODIFICATION TO:INTRODUCER SETS, MODEL ADELANTE AND ADELANTE-SDYB2009-06-04
235631288611935K081986SAFESEPT TRANSSEPTAL TROCAR GUIDEWIREDRC2008-11-14
235631799653712K081052OCCLUSION BALLOON CATHETER, MODEL VENOSDYG2008-06-18
235631468436181K073100INTRODUCER SETS, MODELS ADELANTE AND ADELANTE-SDYB2007-11-30
235631202807214K072770TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM)LDF2008-01-22
235631937919877K070926ELECTRODE/EXTENSION CABLES, MODELS ATARIKD2007-06-07
235631178928989K041809PERMANENT PACING LEAD, MODEL PY2DTB2004-08-06
235631386312201K040569PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJUDTB2004-04-07
235631040163672K031164PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLVDTD2003-06-19
235631236133671K024156PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR,PACING LEAD ADAPTORS, UNIPOLAR/BIPOLARDTD2003-01-14
235632046151528K024053PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJBDTB2003-01-31
235631662766125K020669PERMANENT PACING LEAD, MODELS PETITE, PETITE R, J, RJ, PETITE B, RB, JB, RJBDTB2002-03-28
235631584069350K010787PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONSDTD2001-05-22
235631040163672
235631043415764
235631043973770
235631050135649
235631069013562
235631154189925
235631236133671
235631240148562
235631246599471
235631279079815
235631288579789
235631392411599
235631468436181
235631584069350
235631667071760
235631690085602
235631723645182
235631882276047
235631956006568
235631970433888

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DYB102014-07-09
LDF62008-01-22
DTB52004-08-06
DTD42003-06-19
DRC22014-01-08
DQO12010-01-13
DYG12008-06-18
IKD12007-06-07