Helios Cardio Inc.

Address:11 Dellbrook Road,Weston,MA,02493,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Intracardiac Patch Or Pledget, Biologically Derived (PSQ) (6)

Premarket Exempt

Clear

CardiaMend - 00850023375001 Catalog Number : CMUS-10NS-0612

Device Description : CardiaMend 1.0 Pericardial and Epicardial Reconstruction Matrix 6 x 12 cm

Device Class : 2

Duns Number: 117912350

Premarket Exempt : No

Product Code : PSQ

Prescription Use : Yes

Device Count : 1

CardiaMend - 00850023375018 Catalog Number : CMUS-10NS-0816

Device Description : CardiaMend 1.0 Pericardial and Epicardial Reconstruction Matrix 8 x 16 cm

Device Class : 2

Duns Number: 117912350

Premarket Exempt : No

Product Code : PSQ

Prescription Use : Yes

Device Count : 1

CardiaMend - 00850023375025 Catalog Number : CMUS-10NS-0506

Device Description : CardiaMend 1.0 Pericardial and Epicardial Reconstruction Matrix 5 x 6 cm

Device Class : 2

Duns Number: 117912350

Premarket Exempt : No

Product Code : PSQ

Prescription Use : Yes

Device Count : 1

CardiaMend - 00850023375032 Catalog Number : CMUS-10NS-1015

Device Description : CardiaMend 1.0 Pericardial and Epicardial Reconstruction Matrix 10 x 15 cm

Device Class : 2

Duns Number: 117912350

Premarket Exempt : No

Product Code : PSQ

Prescription Use : Yes

Device Count : 1

CardiaMend - 00850023375049 Catalog Number : CMUS-05NS-0812

Device Description : CardiaMend 0.5 Pericardial and Epicardial Reconstruction Matrix 8 x 12 cm

Device Class : 2

Duns Number: 117912350

Premarket Exempt : No

Product Code : PSQ

Prescription Use : Yes

Device Count : 1

CardiaMend - 00850023375056 Catalog Number : CMUS-05NS-0407

Device Description : CardiaMend 0.5 Pericardial and Epicardial Reconstruction Matrix 4 x 7 cm

Device Class : 2

Duns Number: 117912350

Premarket Exempt : No

Product Code : PSQ

Prescription Use : Yes

Device Count : 1

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