FDA.reportPublic FDA data

Tyke, Patch, Pledget and Intracardiac

Primary DI
00859389005102
Brand
Tyke, Patch, Pledget and Intracardiac
Company
Elutia Med LLC
Model
CMCV-098-204
Device description
Tyke is intended for use in neonates and infants for repair of pericardial structures, as an epicardial covering for damaged or repaired cardiac structures, as a patch material for intracardiac defects, septal defect and annulus repair, suture-line buttressing, and cardiac repair.
Published
2019-02-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXZPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXZPatch, Pledget And Intracardiac, Petp, Ptfe, PolypropyleneCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152127000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152127000CorMatrix TykeCormatrix Cardiovascular, Inc.2016-02-04DXZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10859389005109PackageGS15In Commercial Distribution
00859389005102PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085938900510910859389005109
00859389005102008593890051028593890051020859389005102

GMDN Terms#

Term, Definition table
TermDefinition
Cardiovascular patch, animal-derivedAn implantable material designed to reinforce suture lines and/or increase the strength of weak or injured cardiac and/or peripheral vascular tissues during cardiovascular repair/reconstruction procedures (e.g., annulus or septal defect repair, endarterectomy, profundaplasty). It is a patch made of, or coated/impregnated with, materials of animal origin (e.g., porcine, bovine, or equine pericardium/collagen), that is typically implanted with sutures.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height4Centimeter
Width7Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
470-514-4080xxx@xx.xx

Regulatory Flags#

DUNS number
080924060
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859389005331EluPro Antibiotic-Eluting BioEnvelopeCMCV-124-MED2024-09-06
00859389005348EluPro Antibiotic-Eluting BioEnvelopeCMCV-124-LRG2024-09-06
00859389005010ProxiCor for Pericardial ClosureCMCV-060-4022015-06-30
00859389005027CanGaroo EnvelopeCMCV-009-SML2015-07-01
00859389005034CanGaroo EnvelopeCMCV-009-MED2015-07-01
00859389005041ProxiCor for Cardiac Tissue RepairCMCV-064-4012015-06-30
00859389005058ProxiCor for Cardiac Tissue RepairCMCV-067-4042015-07-01
00859389005065CanGaroo EnvelopeCMCV-009-LRG2015-07-01
00859389005072CanGaroo EnvelopeCMCV-009-XLG2015-07-01
00859389005089VasCure for Carotid RepairCMCV-072-6062015-07-01
00859389005096VasCure for Carotid RepairCMCV-073-6092015-07-01
00859389005119CanGaroo EnvelopeCMCV-009-XXL2019-02-28
00859389005126VasCure for Vascular RepairCMCV-011-6062015-07-01
00859389005140VasCure for Vascular RepairCMCV-013-6092015-07-01
04035479160555Biotronik BioEnvelope4405792019-08-26
04035479160517Biotronik BioEnvelope4405752019-08-26
04035479160524Biotronik BioEnvelope4405762019-08-26
04035479160531Biotronik BioEnvelope4405772019-08-26
04035479160548Biotronik BioEnvelope4405782019-08-26
00859389005003ProxiCor for Pericardial ClosureCMCV-059-4012015-04-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888439624281CARDINAL HEALTHCardinal Health 200, LLCDXZ2019-12-16
14026704634504DEKNATELTELEFLEX INCORPORATEDDXZ2019-11-21
14026704646750DEKNATELTELEFLEX INCORPORATEDDXZ2019-11-20
14026704646767DEKNATELTELEFLEX INCORPORATEDDXZ2019-11-20
14026704646781DEKNATELTELEFLEX INCORPORATEDDXZ2019-11-20
14026704646798DEKNATELTELEFLEX INCORPORATEDDXZ2019-11-20
14026704646804DEKNATELTELEFLEX INCORPORATEDDXZ2019-11-20
10705031462212ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
10705031462229ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
10705031462281ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
10705031462304ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
10705031462335ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
10705031462359ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
10705031462366ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
10705031462373ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
10705031462403ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
14026704638540DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
14026704638557DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
14026704638564DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
14026704638571DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
14026704638588DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
14026704638601DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
14026704638618DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
14026704638625DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
14026704638632DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
14026704638649DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
14026704638656DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
14026704638663DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
14026704634818DEKNATELTELEFLEX INCORPORATEDDXZ2018-07-30
14026704634825DEKNATELTELEFLEX INCORPORATEDDXZ2018-07-30