FDA.reportPublic FDA data

Coronary Artery Perfusion Cannula

Primary DI
10851321006038
Brand
Coronary Artery Perfusion Cannula
Company
VITALCOR, INC
Model
315807
Catalog number
315807
Device description
Coronary Artery Perfusion Cannula with balloon
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
K030231000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K030231000CORONARY ARTERY PERFUSION CANNULA WITH SELF-INFLATING BALLOONSorin Group Italia S.R.L.2003-04-18DWF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10851321006038PackageGS15In Commercial Distribution
00851321006031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085132100603810851321006038
00851321006031008513210060318513210060310851321006031

GMDN Terms#

Term, Definition table
TermDefinition
Cardioplegia solution administration adaptorA sterile device designed to facilitate/regulate the delivery of cardioplegic solution to the heart during a cardiopulmonary bypass procedure by connecting an administration line to a cardioplegia cannula. Also known as a cardioplegia delivery set, it basically consists of tubing [e.g., polyvinyl chloride (PVC)] with connectors. It may have a single lumen or branched multiple-lumen design and include various types of connectors, clamps, and valves, depending on additional intended uses (e.g., venting, recirculation, and/or simultaneous perfusion of vein grafts). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)874-8358info@vitalcor.com

Regulatory Flags#

DUNS number
020942546
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851321006000Coronary Artery Perfusion Cannula3158043158042016-09-16
00851321006017Coronary Artery Perfusion Cannula3158053158052016-09-16
00851321006024Coronary Artery Perfusion Cannula3158063158062016-09-16
00851321006031Coronary Artery Perfusion Cannula3158073158072016-09-16
00851321006048Coronary Artery Perfusion Cannula3158083158082016-09-16
00851321006055Coronary Artery Perfusion Cannula4158044158042016-09-16
00851321006062Coronary Artery Perfusion Cannula4158064158062016-09-16
00851321006079Coronary Artery Perfusion Cannula4158054158052016-09-16
00851321006086Coronary Artery Perfusion Cannula4158074158072016-09-16
00851321006093Coronary Artery Perfusion Cannula4158084158082016-09-16
10851321006007Coronary Artery Perfusion Cannula3158043158042016-09-16
10851321006014Coronary Artery Perfusion Cannula3158053158052016-09-16
10851321006021Coronary Artery Perfusion Cannula3158063158062016-09-16
10851321006045Coronary Artery Perfusion Cannula3158083158082016-09-16
10851321006052Coronary Artery Perfusion Cannula4158044158042016-09-16
10851321006069Coronary Artery Perfusion Cannula4158064158062016-09-16
10851321006076Coronary Artery Perfusion Cannula4158054158052016-09-16
10851321006083Coronary Artery Perfusion Cannula4158074158072016-09-16
10851321006090Coronary Artery Perfusion Cannula4158084158082016-09-16
00851321006499Dingo ClampVA079-06VA079-062016-09-16

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Primary DI, Brand, Company table
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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
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08033178017244Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017251Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11
08033178017268Cardioplegia CannulaSORIN GROUP ITALIA SRLDWF2026-02-11