FDA.reportPublic FDA data

ENABLECV, LLC

Matched from indexed company URL: ENABLECV INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30315717973031571797ENABLECV, LLC1N2026-01-016967 S River Gate Dr. Ste 104 Midvale UT US 84047

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
00840479400228enableCV Dual Stage Venous Drainage Cannula - enableCV Dual Stage Venous Drainage Cannula - TR3651B1(888)943-2783customerservice@enablecv.com
00840479400402enableCV Thin-Flex Dual Stage Venous Drainage Cannula - enableCV Thin-Flex Dual Stage Venous Drainage Cannula -TF3343OA1(888)943-2783customerservice@enablecv.com
00840479401270enableCV Retrograde Cardioplegia Catheter - enableCV Retrograde Cardioplegia Catheter - RC014M1(888)943-2783customerservice@enablecv.com
00840479401294enableCV Retrograde Cardioplegia Catheter - enableCV Retrograde Cardioplegia Catheter - RC091(888)943-2783customerservice@enablecv.com
00840479401317enableCV Retrograde Cardioplegia Catheter - enableCV Retrograde Cardioplegia Catheter - RC09M1(888)943-2783customerservice@enablecv.com
00840479401331enableCV Retrograde Cardioplegia Catheter - enableCV Retrograde Cardioplegia Catheter - RC2012M1(888)943-2783customerservice@enablecv.com
00840479401355enableCV Retrograde Cardioplegia Catheter - enableCV Retrograde Cardioplegia Catheter - RC2014LB1(888)943-2783customerservice@enablecv.com
00840479401379enableCV Retrograde Cardioplegia Catheter - enableCV Retrograde Cardioplegia Catheter - RC2014M1(888)943-2783customerservice@enablecv.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3351411920278563K994243DIRECTFLOW KIT, 24 FR, SOFTCLAMP KIT, 24FR, STRAIGHTSHOT KIT, 23 FR, STRAIGHT TIP, STRAIGHTSHOT KIT, 23 FR, ANGLED TIPDWF2000-05-05
3351411388269416K990396T-ANASTAFLODWF1999-10-01
3351411474164206K981009HEARTPORT ENDOPULMONARY VENT CATHETERDWF1998-09-04
3351411495178794K972570HEARTPORT INTRODUCER SHEATHDYB1997-10-01
3351411083816104K971291HEARTPORT ENDOARTERIAL RETURN CANNULADWF1997-06-17
3351411942357717K964248HEARTPORT ENDOCORONARY SINUS CATHETRDWF1997-01-22
3351411279212321K964161HEARTPORT ENDOAORTIC CLAMPDXC1997-04-04
3351411299230148K962858HEARTPORT ENDOVASCULAR CARDIOPULMONARY BYPASS SYSTEM ANTEGRADE SYTEM (CATALOG NUMBER ECPB-A) ANTEGRADE/RETROGRADE SYSTEMDXC1996-09-30
3351411413182468K962510HEARTPORT ENDOAORTIC CLAMPDXC1996-09-11
3351411972170353K960098RMI INTERNAL MAMMARY ARTERY CANNULADQR1996-03-26
3351411639720533K955132HEARTPORT ENDOAORTIC CLAMPDXC1996-06-07
3351411921146907K922083RMI SURGICCAL SITE VISUALIZATION WANDFQH1993-01-29
3351411987172810K905312DURAFLO II HEPARIN TREATED FEMORAL CANNULAE MODELSDWF1991-01-15
3351411139648878K905311DURAFLO II HEPARIN TREATED SUCTION WANDS VAR. MOD.DWD1991-01-15
3351412042366183K901231RMI CARDIOPLEGIA DELIVERY KITSDWF1990-06-08
3351411447138105K896778RMI VASOPLEGIA CANNULA WITH & WITHOUT CHECK VALVEDWF1990-02-27
3351411712108262K896777RMI AORTIC ROOT PRESSURE MONITOR EXTENSION LINEDWF1990-02-27
3351411111309822K894243RMI ARTERIAL PERFUSION CANNULADQR1989-09-19
3351411773448186K892377RMI AORTIC ROOT/CORONARY SINUS MONIT./INFUSION SETDTL1989-12-07
3351411543491296K861790RMI BALLOON-OCCLUSIVE CAROTID BY-PASS SHUNTDWF1986-07-21
3351411734519099K861322RMI POROUS VENT PLUGDWF1986-05-30
3351411494136530K860988RMI CAROTID BY-PASS SHUNTDWF1986-05-21
3351411774319106K860497CAROTID BALLOON SHUNTDWF1986-05-28
3351411537437297K852456FAP-CATHDQO1985-11-01
3351411921052671K831759INTRACARDIA SUCKERSDWF1983-08-12
3351411304304780K233895EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A, EZF21TA, EZF24A, EZF24TA, EZS21A, EZS21TA, EZS24A and EZS24TA); OptiSite Arterial Perfusion Cannulae (OPTI16, OPTI18, OPTI20 and OPTI22); EndoReturn Arterial Cannulae (ER21B and ER23B);DWF2024-02-05
3351412051396095K200499QuickDraw Venous CannulaDWF2020-03-29
3351411238392319K200358Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula, Femoral Venous Cannula, FemTrak Femoral Venous CannulaDWF2020-03-13
3351412064820828K163693IntraClude Intra-Aortic Occlusion DeviceDXC2017-01-26
3351411722126799K140208FERM-FLEX AND FEM-FLEX II ( FEMORAL ACCESS ARTERIAL CANNULAE) FEMTRAK,VFEM, AND FEM-FLEXIIDWF2014-03-05
3351411735630230K132175EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETERDXC2013-09-13
3351411877029329K131627CATHETER INTRODUCER SHEATHDYB2014-03-06
3351411890660530K123714EDWARDS EMBOL-X INTRODUCER SHEATHDYB2013-07-24
3351412006257644K123370EZ GLIDE AORTIC CANNULA, AORTIC PERFUSION CANNULA WITH DURAFLO COATING, DISPERSION AORTIC PERFUSION CANNULADWF2013-03-13
3351411612350857K123303FEMORAL ACCESS VENOUS CANNULAEDWF2013-03-22
3351411108868842K123298FEM-FELX, FEX-FLEX II FEMORAL ACCESS CANNULA WITH DURAFLO COATINGDWF2013-03-15
3351411142007706K123187RETROGRADE CORONARY SINUS CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CANNULADWF2013-02-22
3351411868761413K121185EDWARDS PERCUTANEOUS SHEATH INTRODUCERDYB2012-08-22
3351411830591625K120780EDWARD PROPLEGE PERIPHERAL RETROGRADE CARDIOPLEGIA DEVICEDWF2012-06-27
3351411385409079K120072VENOUS DRAINAGE CANNULA WITH DURAFLO COATINGDWF2012-05-08
3351411726550095K113667CARDIOPLEGIA DELIVERY SETS CARDIOPLEGIA DELIVERY SETS WITH DURAFLO COATINGDTL2012-01-12
3351411792166589K113459ANTEPLEGIA CATHETER ANTEGRADE CARDIOPLEGIA CATHETER AORTIC ROOT CANNULA ANTEGRADE CATHETER WITH DURAFLO COATINGDWF2012-06-29
3351411704473186K113411EDWARD VENT CATHETERS EDWARD VENT CATHETERS WITH DURAFLO COATING DISPERSION AORTIC PERFUSION CANNULADWF2012-06-11
3351412060783799K113182EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETERDXC2011-12-07
3351411241275764K110103EDWARDS LIFESCIENCES LEFT ATRIAL PRESSURE MONITOR CATHETERDQO2011-02-11
3351411990030839K102420EMBOL-X ACCESS DEVICE/ AORTIC CANNULA, EMBOL-X SLIM ACCESSDEVICE/ AORTIC CANNULA, EMBOL-X GLIDE ACCESS DEVICE/ AORTIC CADWF2010-10-26
3351411386309015K093730PORT ACCESS SYSTEMS ENDODIRECT ARTERIAL CANNULA MODEL ED24 (OLD CODE WAS-DFK24)DWF2010-01-14
3351411735649915K093554RETROFLEX DILATOR KITDRE2010-04-13
3351411102359822K07355918 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA IIDQR2008-01-31
3351411921150162K062429MODIFICATION TO EMBOL-X INTRA-AORTIC FILTER: X-SMALL, SMALL, MEDIUM, LARGE, X-LARGE WITH HEPARIN COATED MESHDTM2006-09-27
3351411829394492K033463EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC ARTERIAL CANNULAEDWF2004-07-28
3351412006412772K031946EMBOL-X INTRA-AORTIC FILTER: EXTRA-SMALL, SMALL, MEDIUM, LARGE, EXTRA-LARGEDTM2003-11-03
3351411710806418K022071EMBOL-X AORTIC FILTERS,ETRA-SMALL,SMALL,MEDIUM,LARGE,EXTRA LARGE,MODELS CF26000.CF29000,CF32000,CF35000,CF4000DTM2003-02-14
3351411934801812K002578AXILLARY ACCESS ARTERIAL CANNULADWF2002-04-11
3351411089276535

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DWF302024-02-05
DXC72017-01-26
DYB42014-03-06
DQR32008-01-31
DTM32006-09-27
DTL22012-01-12
DQO22011-02-11
DRE12010-04-13
FQH11993-01-29
DWD11991-01-15

GUDID#

151 records. Showing 1-40. Next