Data / Medical devices / United States / Enablecv, LLC
Enablecv, LLC: FDA-registered device maker in Midvale, UT, United States, 54 510(k) clearances
Enablecv, LLC is registered with the FDA (registration 3031571797) in Midvale, UT, United States. It lists 11 device types. The FDA files 54 510(k) clearances under its listings, the newest dated February 5, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3031571797
- Address
- 6967 S River Gate Dr. Ste 104, Midvale, UT, United States, 84047
- Owner or operator
- enableCV, LLC (10092279)
- Roles
- Specification developer
- First device listed
- December 19, 2024
- Registered through
- 2026
- Brand names listed
- Anastaflo Intravascular Shunts, Antegrade Cardioplegia Cannula, Aortic Perfusion Cannulae; Pediatric Peripheral access arterial cannula, Arterial Cannula Families (EZ Glide, OptiSite and EndoReturn), Arterial Perfusion Cannulae, Axillary Access Arterial Cannulae, Cardioplegia Delivery Sets, Cardioplegia Kits and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | DTL | 2 | Specification developer | accessdata.fda.gov |
| Cannula, Catheter | DQR | 2 | Specification developer | accessdata.fda.gov |
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | DWF | 2 | Specification developer | accessdata.fda.gov |
| Catheter, Intravascular, Diagnostic | DQO | 2 | Specification developer | accessdata.fda.gov |
| Clamp, Vascular | DXC | 2 | Specification developer | accessdata.fda.gov |
| Dilator, Vessel, For Percutaneous Catheterization | DRE | 2 | Specification developer | accessdata.fda.gov |
| Filter, Blood, Cardiopulmonary Bypass, Arterial Line | DTM | 2 | Specification developer | accessdata.fda.gov |
| Introducer, Catheter | DYB | 2 | Specification developer | accessdata.fda.gov |
| Lavage, Jet | FQH | 2 | Specification developer | accessdata.fda.gov |
| Stabilizer, Heart | MWS | 1 | Specification developer | accessdata.fda.gov |
| Suction Control, Intracardiac, Cardiopulmonary Bypass | DWD | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 5, 2024 | K233895 | EZ 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); | DWF | Substantially Equivalent | Edwards Lifesciences | accessdata.fda.gov |
| March 29, 2020 | K200499 | QuickDraw Venous Cannula | DWF | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| March 13, 2020 | K200358 | Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula, Femoral Venous Cannula, FemTrak Femoral Venous Cannula | DWF | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| January 26, 2017 | K163693 | IntraClude Intra-Aortic Occlusion Device | DXC | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| March 6, 2014 | K131627 | CATHETER INTRODUCER SHEATH | DYB | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| March 5, 2014 | K140208 | FERM-FLEX AND FEM-FLEX II ( FEMORAL ACCESS ARTERIAL CANNULAE) FEMTRAK,VFEM, AND FEM-FLEXII | DWF | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| September 13, 2013 | K132175 | EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER | DXC | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| July 24, 2013 | K123714 | EDWARDS EMBOL-X INTRODUCER SHEATH | DYB | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| March 22, 2013 | K123303 | FEMORAL ACCESS VENOUS CANNULAE | DWF | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| March 15, 2013 | K123298 | FEM-FELX, FEX-FLEX II FEMORAL ACCESS CANNULA WITH DURAFLO COATING | DWF | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| March 13, 2013 | K123370 | EZ GLIDE AORTIC CANNULA, AORTIC PERFUSION CANNULA WITH DURAFLO COATING, DISPERSION AORTIC PERFUSION CANNULA | DWF | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| February 22, 2013 | K123187 | RETROGRADE CORONARY SINUS CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CANNULA | DWF | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| August 22, 2012 | K121185 | EDWARDS PERCUTANEOUS SHEATH INTRODUCER | DYB | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| June 29, 2012 | K113459 | ANTEPLEGIA CATHETER ANTEGRADE CARDIOPLEGIA CATHETER AORTIC ROOT CANNULA ANTEGRADE CATHETER WITH DURAFLO COATING | DWF | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| June 27, 2012 | K120780 | EDWARD PROPLEGE PERIPHERAL RETROGRADE CARDIOPLEGIA DEVICE | DWF | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| June 11, 2012 | K113411 | EDWARD VENT CATHETERS EDWARD VENT CATHETERS WITH DURAFLO COATING DISPERSION AORTIC PERFUSION CANNULA | DWF | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| May 8, 2012 | K120072 | VENOUS DRAINAGE CANNULA WITH DURAFLO COATING | DWF | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| January 12, 2012 | K113667 | CARDIOPLEGIA DELIVERY SETS CARDIOPLEGIA DELIVERY SETS WITH DURAFLO COATING | DTL | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| December 7, 2011 | K113182 | EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER | DXC | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| February 11, 2011 | K110103 | EDWARDS LIFESCIENCES LEFT ATRIAL PRESSURE MONITOR CATHETER | DQO | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| October 26, 2010 | K102420 | EMBOL-X ACCESS DEVICE/ AORTIC CANNULA, EMBOL-X SLIM ACCESSDEVICE/ AORTIC CANNULA, EMBOL-X GLIDE ACCESS DEVICE/ AORTIC CA | DWF | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| April 13, 2010 | K093554 | RETROFLEX DILATOR KIT | DRE | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| January 14, 2010 | K093730 | PORT ACCESS SYSTEMS ENDODIRECT ARTERIAL CANNULA MODEL ED24 (OLD CODE WAS-DFK24) | DWF | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| January 31, 2008 | K073559 | 18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA II | DQR | Substantially Equivalent | Edwards Lifesciences Research Medical | accessdata.fda.gov |
| September 27, 2006 | K062429 | MODIFICATION TO EMBOL-X INTRA-AORTIC FILTER: X-SMALL, SMALL, MEDIUM, LARGE, X-LARGE WITH HEPARIN COATED MESH | DTM | Substantially Equivalent | Edwards Lifesciences Research Medical | accessdata.fda.gov |
| July 28, 2004 | K033463 | EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC ARTERIAL CANNULAE | DWF | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| November 3, 2003 | K031946 | EMBOL-X INTRA-AORTIC FILTER: EXTRA-SMALL, SMALL, MEDIUM, LARGE, EXTRA-LARGE | DTM | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| February 14, 2003 | K022071 | EMBOL-X AORTIC FILTERS,ETRA-SMALL,SMALL,MEDIUM,LARGE,EXTRA LARGE,MODELS CF26000.CF29000,CF32000,CF35000,CF4000 | DTM | Substantially Equivalent | Embol-X, Inc. | accessdata.fda.gov |
| April 11, 2002 | K002578 | AXILLARY ACCESS ARTERIAL CANNULA | DWF | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| May 5, 2000 | K994243 | DIRECTFLOW KIT, 24 FR, SOFTCLAMP KIT, 24FR, STRAIGHTSHOT KIT, 23 FR, STRAIGHT TIP, STRAIGHTSHOT KIT, 23 FR, ANGLED TIP | DWF | Substantially Equivalent | Heartport, Inc. | accessdata.fda.gov |
| October 1, 1999 | K990396 | T-ANASTAFLO | DWF | Substantially Equivalent | Edwards Lifesciences Research Medical | accessdata.fda.gov |
| September 4, 1998 | K981009 | HEARTPORT ENDOPULMONARY VENT CATHETER | DWF | Substantially Equivalent | Heartport, Inc. | accessdata.fda.gov |
| October 1, 1997 | K972570 | HEARTPORT INTRODUCER SHEATH | DYB | Substantially Equivalent | Heartport, Inc. | accessdata.fda.gov |
| June 17, 1997 | K971291 | HEARTPORT ENDOARTERIAL RETURN CANNULA | DWF | Substantially Equivalent | Heartport, Inc. | accessdata.fda.gov |
| April 4, 1997 | K964161 | HEARTPORT ENDOAORTIC CLAMP | DXC | Substantially Equivalent | Heartport, Inc. | accessdata.fda.gov |
| January 22, 1997 | K964248 | HEARTPORT ENDOCORONARY SINUS CATHETR | DWF | Substantially Equivalent | Heartport, Inc. | accessdata.fda.gov |
| September 30, 1996 | K962858 | HEARTPORT ENDOVASCULAR CARDIOPULMONARY BYPASS SYSTEM ANTEGRADE SYTEM (CATALOG NUMBER ECPB-A) ANTEGRADE/RETROGRADE SYSTEM | DXC | Substantially Equivalent | Heartport, Inc. | accessdata.fda.gov |
| September 11, 1996 | K962510 | HEARTPORT ENDOAORTIC CLAMP | DXC | Substantially Equivalent | Heartport, Inc. | accessdata.fda.gov |
| June 7, 1996 | K955132 | HEARTPORT ENDOAORTIC CLAMP | DXC | Substantially Equivalent | Heartport, Inc. | accessdata.fda.gov |
| March 26, 1996 | K960098 | RMI INTERNAL MAMMARY ARTERY CANNULA | DQR | Substantially Equivalent | Research Medical, Inc. | accessdata.fda.gov |
| January 29, 1993 | K922083 | RMI SURGICCAL SITE VISUALIZATION WAND | FQH | Substantially Equivalent | Research Medical, Inc. | accessdata.fda.gov |
| January 15, 1991 | K905312 | DURAFLO II HEPARIN TREATED FEMORAL CANNULAE MODELS | DWF | Substantially Equivalent | Baxter Bentley Laboratories, Inc. | accessdata.fda.gov |
| January 15, 1991 | K905311 | DURAFLO II HEPARIN TREATED SUCTION WANDS VAR. MOD. | DWD | Substantially Equivalent | Baxter Bentley Laboratories, Inc. | accessdata.fda.gov |
| June 8, 1990 | K901231 | RMI CARDIOPLEGIA DELIVERY KITS | DWF | Substantially Equivalent | Research Medical, Inc. | accessdata.fda.gov |
| February 27, 1990 | K896778 | RMI VASOPLEGIA CANNULA WITH & WITHOUT CHECK VALVE | DWF | Substantially Equivalent | Research Medical, Inc. | accessdata.fda.gov |
| February 27, 1990 | K896777 | RMI AORTIC ROOT PRESSURE MONITOR EXTENSION LINE | DWF | Substantially Equivalent | Research Medical, Inc. | accessdata.fda.gov |
| December 7, 1989 | K892377 | RMI AORTIC ROOT/CORONARY SINUS MONIT./INFUSION SET | DTL | Substantially Equivalent | Research Medical, Inc. | accessdata.fda.gov |
| September 19, 1989 | K894243 | RMI ARTERIAL PERFUSION CANNULA | DQR | Substantially Equivalent | Research Medical, Inc. | accessdata.fda.gov |
| July 21, 1986 | K861790 | RMI BALLOON-OCCLUSIVE CAROTID BY-PASS SHUNT | DWF | Substantially Equivalent | Research Medical, Inc. | accessdata.fda.gov |
| May 30, 1986 | K861322 | RMI POROUS VENT PLUG | DWF | Substantially Equivalent | Research Medical, Inc. | accessdata.fda.gov |
| May 28, 1986 | K860497 | CAROTID BALLOON SHUNT | DWF | Substantially Equivalent | Imodex, Inc. | accessdata.fda.gov |
| May 21, 1986 | K860988 | RMI CAROTID BY-PASS SHUNT | DWF | Substantially Equivalent | Research Medical, Inc. | accessdata.fda.gov |
| November 1, 1985 | K852456 | FAP-CATH | DQO | Substantially Equivalent | Research Medical, Inc. | accessdata.fda.gov |
| August 12, 1983 | K831759 | INTRACARDIA SUCKERS | DWF | Substantially Equivalent | Research Industries Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- All makers of Clamp, Vascular
- All makers of Filter, Blood, Cardiopulmonary Bypass, Arterial Line
- All makers of Catheter, Intravascular, Diagnostic
- All makers of Introducer, Catheter
Updated February 5, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.