VM CARDIO VASCULAR, INC.

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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

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (DWF) (2) Clamp, Vascular (DXC) (2) Marker, Ostia, Aorto-Saphenous Vein (KPK) (2)

Premarket Exempt

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Voss Coronary Bypass Sterile Marker - 00811304020041 Catalog Number :

Device Description : Coronary Bypass Graft Marker (sterile)

Device Class : 2

Duns Number: 799240457

Premarket Exempt : No

Product Code : KPK

Prescription Use : Yes

Device Count : 1

Voss Coronary Bypass Vein Clamp - 00811304020058 Catalog Number :

Device Description : Coronary Bypass Vein Clamp

Device Class : 2

Duns Number: 799240457

Premarket Exempt : No

Product Code : DXC

Prescription Use : Yes

Device Count : 1

Voss Coronary Bypass Vein Flushing Cannula - 00811304020065 Catalog Number :

Device Description : Vein flushing Cannula for Coronary Bypass (sterile)

Device Class : 2

Duns Number: 799240457

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

Voss Non-Sterile Coronary Bypass Graft Marker - 00811304020072 Catalog Number :

Device Description : Coronary Bypass Graft Marker-Non-sterile

Device Class : 2

Duns Number: 799240457

Premarket Exempt : No

Product Code : KPK

Prescription Use : Yes

Device Count : 1

Voss Coronary Bypass Vein Clamp - 00811304020089 Catalog Number :

Device Description : Coronary Bypass Vein Clamp (non-sterile)

Device Class : 2

Duns Number: 799240457

Premarket Exempt : No

Product Code : DXC

Prescription Use : Yes

Device Count : 1

Voss Coronary Bypass Vein Flushing Cannula - 00811304020096 Catalog Number :

Device Description : Coronary Bypass Vein Flushing Cannula (non-sterile)

Device Class : 2

Duns Number: 799240457

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

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