FDA.reportPublic FDA data

ThruPort Systems EndoReturn Arterial Cannula Kit

Primary DI
00690103191417
Brand
ThruPort Systems EndoReturn Arterial Cannula Kit
Company
Edwards Lifesciences LLC
Model
ER23B
Catalog number
ER23B
Device description
Arterial Cannula Kit
Published
2016-08-31
Public version status
Update
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
K971291000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K971291000HEARTPORT ENDOARTERIAL RETURN CANNULAHeartport, Inc.1997-06-17DWF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00690103191417PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00690103191417006901031914176901031914170690103191417

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass cannula, arterialA sterile, semi-rigid or rigid tube intended to be used during open heart surgery where it is surgically inserted for perfusion of the ascending aorta, serving as a channel for the transport of pumped, oxygenated, blood from a cardiopulmonary bypass system (heart-lung machine) tubing circuit. It is typically a moulded plastic tube with stainless steel wire reinforcement, to prevent kinking/collapse, having multiple perforations or flutes at the distal end which help diffuse and disperse incoming blood. It may be inserted using a compatible trocar. Some types may be heparin coated and include a pressure monitoring port. 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(800)822-9637tech_support@edwards.com

Regulatory Flags#

DUNS number
134139174
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00690103220223TRIFORMIS RESILIA Tricuspid Valve11300T2511300T252026-05-28
00690103220230TRIFORMIS RESILIA Tricuspid Valve11300T2711300T272026-05-28
00690103220247TRIFORMIS RESILIA Tricuspid Valve11300T2911300T292026-05-28
00690103220254TRIFORMIS RESILIA Tricuspid Valve11300T3111300T312026-05-28
00690103220261TRIFORMIS RESILIA Tricuspid Valve11300T3311300T332026-05-28
00690103019643HEART VALVE ACCESSORY1170117019MM2026-04-06
00690103019650HEART VALVE ACCESSORY1170117021MM2026-04-06
00690103019674HEART VALVE ACCESSORY1170117025MM2026-04-06
00690103019698HEART VALVE ACCESSORY1170117029MM2026-04-06
00690103019704HEART VALVE ACCESSORY1174M1174M242026-04-06
00690103019711HEART VALVE ACCESSORY1174M1174M262026-04-06
00690103019728HEART VALVE ACCESSORY1174M1174M282026-04-06
00690103019735HEART VALVE ACCESSORY1174M1174M302026-04-06
00690103019742HEART VALVE ACCESSORY1174M1174M322026-04-06
00690103019759HEART VALVE ACCESSORY1174M1174M342026-04-06
00690103019766HEART VALVE ACCESSORY1174M1174M362026-04-06
00690103019773HEART VALVE ACCESSORY1174M1174M382026-04-06
00690103019780HEART VALVE ACCESSORY1174M1174M402026-04-06
00690103019797HEART VALVE ACCESSORY1175T1175T262026-04-06
00690103019803HEART VALVE ACCESSORY1175T1175T282026-04-06

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