FDA.reportPublic FDA data

CardiaMend

Primary DI
00850023375018
Brand
CardiaMend
Company
Helios Cardio Inc.
Model
CMUS-10NS-0816
Catalog number
CMUS-10NS-0816
Device description
CardiaMend 1.0 Pericardial and Epicardial Reconstruction Matrix 8 x 16 cm
Published
2022-02-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PSQIntracardiac Patch Or Pledget, Biologically Derived

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PSQIntracardiac Patch Or Pledget, Biologically DerivedCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210331000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210331000CardiaMend Pericardial and Epicardial Reconstruction MatrixHelios Cardio, Inc.2021-12-21PSQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850023375018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850023375018008500233750188500233750180850023375018

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
Height1Millimeter
Length8Centimeter
Width16Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Away from Excessive Heat
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-339-707-7788support@helioscardio.com

Regulatory Flags#

DUNS number
117912350
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850023375087CardiaMendCMUS-05NS-0506CMUS-05NS-05062023-07-07
00850023375063CardiaMendCMUS-10NS-0812CMUS-10NS-08122022-12-13
00850023375070CardiaMendCMUS-10NS-0715CMUS-10NS-07152022-12-13
00850023375001CardiaMendCMUS-10NS-0612CMUS-10NS-06122022-02-01
00850023375025CardiaMendCMUS-10NS-0506CMUS-10NS-05062022-02-01
00850023375032CardiaMendCMUS-10NS-1015CMUS-10NS-10152022-02-01
00850023375049CardiaMendCMUS-05NS-0812CMUS-05NS-08122022-02-01
00850023375056CardiaMendCMUS-05NS-0407CMUS-05NS-04072022-02-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00877234001635PhotoFix Decellularized Bovine PericardiumArtivion, Inc.PSQ2026-05-29
00877234001642PhotoFix Decellularized Bovine PericardiumArtivion, Inc.PSQ2026-05-29
00877234001659PhotoFix Decellularized Bovine PericardiumArtivion, Inc.PSQ2026-05-29
00877234001666PhotoFix Decellularized Bovine PericardiumArtivion, Inc.PSQ2026-05-29
00877234001673PhotoFix Decellularized Bovine PericardiumArtivion, Inc.PSQ2026-05-29
00877234001680PhotoFix Decellularized Bovine PericardiumArtivion, Inc.PSQ2026-05-29
00877234001697PhotoFix Decellularized Bovine PericardiumArtivion, Inc.PSQ2026-05-29
00877234001703PhotoFix Decellularized Bovine PericardiumArtivion, Inc.PSQ2026-05-29
00850023375087CardiaMendHelios Cardio Inc.PSQ2023-07-07
00085412818313Supple Peri-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2023-05-15
00085412818375Supple Peri-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2023-05-15
00085412818405Peri-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2023-05-15
00085412818429Supple Peri-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2023-05-15
00085412818443Peri-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2023-05-15
00085412818597Peri-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2023-05-15
00085412818610Peri-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2023-05-15
00085412818658Peri-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2023-05-15
00085412818672Supple Peri-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2023-05-15
00085412818696Supple Peri-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2023-05-15
00850023375063CardiaMendHelios Cardio Inc.PSQ2022-12-13
00850023375070CardiaMendHelios Cardio Inc.PSQ2022-12-13
00085412818474Vascu-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2022-11-28
00085412818498Vascu-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2022-11-28
00085412818511Vascu-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2022-11-28
00085412818535Vascu-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2022-11-28
00085412818559Vascu-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2022-11-28
00085412818573Vascu-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2022-11-28
00085412818634Vascu-GuardSYNOVIS LIFE TECHNOLOGIES, INC.PSQ2022-11-28
00850023375001CardiaMendHelios Cardio Inc.PSQ2022-02-01
00850023375025CardiaMendHelios Cardio Inc.PSQ2022-02-01