CARDIVA MEDICAL, INC.

Address:Carretera Internacional Km. 129, Salida Norte de Guaymas,Guaymas Sonora,MX

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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

Device, Hemostasis, Vascular (MGB) (3) Clamp, Vascular (DXC) (2)

Premarket Exempt

No Yes

Clear

Cardiva Catalyst II VCS - M729500580C0 Catalog Number :

Device Description : The Cardiva Catalyst™ II consists of a sterile disposable Catalyst II Wire and a The Cardiva Catalyst™ II consists of a sterile disposable Catalyst II Wire and a sterile disposable Catalyst Clip. The Cardiva Catalyst II System is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The Cardiva Catalyst II is indicated for use in patients undergoing diagnostic and/or interventional femoral artery catheterization procedures, using 5F, 6F or 7F introducer sheaths.

Device Class : 2

Duns Number: 128112195

Premarket Exempt : Yes

Product Code : DXC

Prescription Use : Yes

Device Count : 1

Cardiva Catalyst III VCS - M729600580CP0 Catalog Number :

Device Description : The Cardiva Catalyst III consists of a sterile disposable Catalyst III Wire and The Cardiva Catalyst III consists of a sterile disposable Catalyst III Wire and a sterile disposable Catalyst Clip. The Cardiva Catalyst III is specifically designed for use with heparinized patients. The Cardiva Catalyst III System with Protamine Sulfate is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression in heparinized patients. The Cardiva Catalyst III is indicated for use in patients undergoing diagnostic and/or interventional femoral artery catheterization procedures, using 5F, 6F or 7F introducer sheaths.

Device Class : 2

Duns Number: 128112195

Premarket Exempt : Yes

Product Code : DXC

Prescription Use : Yes

Device Count : 1

Cardiva VASCADE 5F VCS - M729700500DX0 Catalog Number :

Device Description : The VASCADE VCS is intended to seal femoral vessel puncture sites at the complet The VASCADE VCS is intended to seal femoral vessel puncture sites at the completion of catheter-based procedures. The system is designed to deliver a resorbable Collagen Patch, extra-vascularly, at the vessel puncture site to achieve hemostasis. For use in 5F introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm.

Device Class :

Duns Number: 128112195

Premarket Exempt : No

Product Code : MGB

Prescription Use : Yes

Device Count : 1

Cardiva VASCADE 6/7F VCS - M729700580I0 Catalog Number :

Device Description : The VASCADE VCS is intended to seal femoral vessel puncture sites at the complet The VASCADE VCS is intended to seal femoral vessel puncture sites at the completion of catheter-based procedures. The system is designed to deliver a resorbable Collagen Patch, extra-vascularly, at the vessel puncture site to achieve hemostasis. For use in 6F & 7F introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm.

Device Class :

Duns Number: 128112195

Premarket Exempt : No

Product Code : MGB

Prescription Use : Yes

Device Count : 1

Cardiva VASCADE MVP VVCS 6-12F - M729800612C0 Catalog Number :

Device Description : The VASCADE MVP Venous Vascular Closure System (VVCS) is intended to seal femora The VASCADE MVP Venous Vascular Closure System (VVCS) is intended to seal femoral veins with single or multiple access sites in one or both limbs at the completion of catheterization procedures. The system is designed to deliver a resorbable Collagen Patch, extra-vascularly, at vessel puncture sites to achieve hemostasis. For use with 6Fr to 12Fr (15F maximum outer diameter) introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm.

Device Class :

Duns Number: 128112195

Premarket Exempt : No

Product Code : MGB

Prescription Use : Yes

Device Count : 1

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