FDA.reportPublic FDA data

enableCV ProPlege Peripheral Retrograde Cardioplegia Device

Primary DI
00840479400013
Brand
enableCV ProPlege Peripheral Retrograde Cardioplegia Device
Company
ENABLECV INC.
Model
PR9
Catalog number
PR9
Device description
ProPlege Peripheral Retrograde Cardioplegia Device
Published
2025-04-09
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
K120780000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120780000EDWARD PROPLEGE PERIPHERAL RETROGRADE CARDIOPLEGIA DEVICEEdwards Lifesciences, LLC2012-06-27DWF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840479400010PackageGS11In Commercial Distribution
00840479400013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084047940001010840479400010
00840479400013008404794000138404794000130840479400013

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
Device Size Text, specify0

Storage And Handling#

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

Sterilization Methods#

Method table
Method

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
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
00840479401355enableCV Retrograde Cardioplegia CatheterRC2014LB2026-04-30
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
00840479401690enableCV ThinFlex Single Stage Venous Drainage CannulaTF024L2026-04-27
00840479401973enableCV ThinFlex Single Stage Venous Drainage CannulaTF016L2026-04-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00199150083817NAMEDTRONIC, INC.DWF2026-05-30
00199150083893NAMEDTRONIC, INC.DWF2026-05-30
00199150083985NAMEDTRONIC, INC.DWF2026-05-30
18051160302878Quantum SuperPAC Tubing Set - SP05E-BBSPECTRUM MEDICAL SRLDWF2026-05-27
00199150078455NAMEDTRONIC, INC.DWF2026-04-26
08033178017190Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017206Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017213Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017220Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017237Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017244Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017251Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017268Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017275Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017312Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178018074Coronary Sinus CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178018098Coronary Sinus CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178018104Coronary Sinus CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178019026Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178019033Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178019040Ventricular Vent CatheterSORIN GROUP ITALIA SRLDWF2026-02-11