FDA.reportPublic FDA data

enableCV Retrograde Cardioplegia Catheter

Primary DI
00840479401355
Brand
enableCV Retrograde Cardioplegia Catheter
Company
ENABLECV INC.
Model
RC2014LB
Device description
enableCV Retrograde Cardioplegia Catheter - RC2014LB
Published
2026-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123187000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123187000RETROGRADE CORONARY SINUS CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CANNULAEdwards Lifesciences, LLC2013-02-22DWF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840479401362PackageGS110In Commercial Distribution
00840479401355PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840479401362008404794013628404794013620840479401362
00840479401355008404794013558404794013550840479401355

GMDN Terms#

Term, Definition table
TermDefinition
Coronary sinus cannulaA sterile, rigid or semi-rigid tube designed to be surgically inserted, temporarily, into the ostium of the coronary sinus to provide retrograde coronary perfusion/cardioplegia during cardiopulmonary bypass or minimally invasive surgery. It may be equipped with a self-inflating low pressure balloon that is typically used for back flushing the coronary vessel in the event of inadvertent coronary air embolization. Insertion is achieved with the use of a removable stylet or trocar. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store sterile packaged device in a cool, dry place.

Contacts#

Phone, Email table
PhoneEmail
1(888)943-2783customerservice@enablecv.com

Regulatory Flags#

DUNS number
119247843
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840479401416enableCV EZ Glide Aortic CannulaEZF21A2026-07-09
00840479401430enableCV EZ Glide Aortic CannulaEZF24A2026-07-09
00840479402222enableCV Percutaneous Insertion Kit-ArterialPIKA2026-06-26
00840479400228enableCV Dual Stage Venous Drainage CannulaTR3651B2026-04-30
00840479400402enableCV Thin-Flex Dual Stage Venous Drainage CannulaTF3343OA2026-04-30
00840479401270enableCV Retrograde Cardioplegia CatheterRC014M2026-04-30
00840479401294enableCV Retrograde Cardioplegia CatheterRC092026-04-30
00840479401317enableCV Retrograde Cardioplegia CatheterRC09M2026-04-30
00840479401331enableCV Retrograde Cardioplegia CatheterRC2012M2026-04-30
00840479401379enableCV Retrograde Cardioplegia CatheterRC2014M2026-04-30
00840479401478enableCV AViD Dual Stage Venous Drainage CannulaTF2929012026-04-30
00840479401515enableCV Thin-Flex Dual Stage Venous Drainage CannulaTF2937O2026-04-30
00840479401553enableCV Thin-Flex Dual Stage Venous Drainage CannulaTF3646O1202026-04-30
00840479400594enableCV Thin-Flex Single Stage Venous Drainage CannulaTF034L2026-04-27
00840479401577enableCV ThinFlex Single Stage Venous Drainage CannulaTF012L2026-04-27
00840479401591enableCV ThinFlex Single Stage Venous Drainage CannulaTF014L2026-04-27
00840479401614 enableCV ThinFlex Single Stage Venous Drainage CannulaTF018L2026-04-27
00840479401638enableCV ThinFlex Single Stage Venous Drainage CannulaTF018O902026-04-27
00840479401652enableCV ThinFlex Single Stage Venous Drainage CannulaTF020L2026-04-27
00840479401676enableCV ThinFlex Single Stage Venous Drainage CannulaTF022L2026-04-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00824846003151NAMEDTRONIC, INC.DWF2026-07-09
00840479401416enableCV EZ Glide Aortic CannulaENABLECV INC.DWF2026-07-09
00840479401430enableCV EZ Glide Aortic CannulaENABLECV INC.DWF2026-07-09
00824846003472NAMEDTRONIC, INC.DWF2026-07-04
00824846003687NAMEDTRONIC, INC.DWF2026-07-04
00824846003700NAMEDTRONIC, INC.DWF2026-07-04
00824846001669NAMEDTRONIC, INC.DWF2026-06-28
00824846001843NAMEDTRONIC, INC.DWF2026-06-28
00824846001850NAMEDTRONIC, INC.DWF2026-06-28
00840479402222enableCV Percutaneous Insertion Kit-ArterialENABLECV INC.DWF2026-06-26
00824846001614NAMEDTRONIC, INC.DWF2026-06-25
08033178019378Protek DuoSORIN GROUP ITALIA SRLDWF2026-06-25
08033178019385Protek DuoSORIN GROUP ITALIA SRLDWF2026-06-25
00199150083855NAMEDTRONIC, INC.DWF2026-06-08
00199150083992NAMEDTRONIC, INC.DWF2026-06-08
00199150084180NAMEDTRONIC, INC.DWF2026-06-08
00824846000020NAMEDTRONIC, INC.DWF2026-06-08
00824846000983NAMEDTRONIC, INC.DWF2026-06-08
00824846001027NAMEDTRONIC, INC.DWF2026-06-08
00824846001041NAMEDTRONIC, INC.DWF2026-06-08
00824846001065NAMEDTRONIC, INC.DWF2026-06-08
00199150083077NAMEDTRONIC, INC.DWF2026-05-30
00199150083121NAMEDTRONIC, INC.DWF2026-05-30
00199150083381NAMEDTRONIC, INC.DWF2026-05-30
00199150083442NAMEDTRONIC, INC.DWF2026-05-30
00199150083534NAMEDTRONIC, INC.DWF2026-05-30
00199150083718NAMEDTRONIC, INC.DWF2026-05-30
00199150083763NAMEDTRONIC, INC.DWF2026-05-30
00199150083794NAMEDTRONIC, INC.DWF2026-05-30
00199150083800NAMEDTRONIC, INC.DWF2026-05-30