FDA.reportPublic FDA data

Cardiva Medical, Inc.

Matched from indexed company URL: CARDIVA MEDICAL, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30114693553011469355Cardiva Medical, Inc.1N2026-01-01Carretera Internacional Km. 129, Salida Norte de Guaymas Parque Industrial Rocafuerte Guaymas Sonora MX 85340
30151454973015145497Cardiva Medical, Inc.1Y2026-01-011615 Wyatt Drive Santa Clara CA US 95054

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
M729500580C0Cardiva Catalyst II VCS - 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.+1-408-470-7170customerservice@cardivamedical.com
M729500580C2Cardiva Catalyst II VCS - 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.+1-408-470-7170customerservice@cardivamedical.com
M729600580CP0Cardiva Catalyst III VCS - 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.+1-408-470-7170customerservice@cardivamedical.com
M729700500DX0Cardiva VASCADE 5F VCS - 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.+1-408-470-7170customerservice@cardivamedical.com
M729700500DX0Cardiva VASCADE 5F VCS - 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.+1-408-470-7170CustomerServiceNA@haemonetics.com
M729700580I0Cardiva VASCADE 6/7F VCS - 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.+1-408-470-7170CustomerServiceNA@haemonetics.com
M729700580I0Cardiva VASCADE 6/7F VCS - 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.+1-408-470-7170customerservice@cardivamedical.com
M7298001012XL0Cardiva VASCADE MVP XL VVCS 10-12F - The VASCADE MVP XL Venous Vascular Closure System (VVCS) 10-12F 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 10Fr to 12Fr (15F maximum outer diameter) introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm.+1-800-537-2802customerserviceNA@haemonetics.com
M7298001012XL2Cardiva VASCADE MVP XL VVCS 10-12F - The VASCADE MVP XL Venous Vascular Closure System (VVCS) 10-12F 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 10Fr to 12Fr (15F maximum outer diameter) introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm.+1-800-537-2802customerserviceNA@haemonetics.com
M7298001014XL0VASCADE MVP XL VVCS - The VASCADE MVP XL 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 10F to 14F (17F maximum outer diameter) introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm.+1-800-537-2802customerserviceNA@haemonetics.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1846191302195036P120016VASCADE VASCULAR CLOSURE SYSTEMMGB2013-01-31
2245031302195036P120016VASCADE VASCULAR CLOSURE SYSTEMMGB2013-01-31
2245032041632465P080029QUICK-CLOSE VASCULAR SUTURING SYSTEM (QUICK-CLOSE SYSTEM)MGB2010-04-08
1846191489397024K130124CATALYST II AND IIIDXC2013-03-14
2245031489397024K130124CATALYST II AND IIIDXC2013-03-14

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MGB32013-01-31
DXC22013-03-14
MGB 12010-04-08

PMA#

PMN#

GUDID#