Cardiva VASCADE 6/7F VCS

GUDID M729700580I1

The VASCADE VCS is intended to seal the femoral arterial access site at the completion of an endovascular procedure. The system is designed to deliver a resorbable Collagen Patch, extra-vascularly, at the arteriotomy site to aid in achieving hemostasis. For use in 6F & 7F introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm.

CARDIVA MEDICAL, INC.

Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen Femoral artery closure plug/patch, collagen
Primary Device IDM729700580I1
NIH Device Record Keya2fb250d-3cd4-4851-8248-0f9a5d5f26f0
Commercial Distribution StatusIn Commercial Distribution
Brand NameCardiva VASCADE 6/7F VCS
Version Model Number700-580I
Company DUNS128112195
Company NameCARDIVA MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1-408-470-7170
Emailcustomerservice@cardivamedical.com
Phone+1-408-470-7170
Emailcustomerservice@cardivamedical.com
Phone+1-408-470-7170
Emailcustomerservice@cardivamedical.com
Phone+1-408-470-7170
Emailcustomerservice@cardivamedical.com
Phone+1-408-470-7170
Emailcustomerservice@cardivamedical.com
Phone+1-408-470-7170
Emailcustomerservice@cardivamedical.com
Phone+1-408-470-7170
Emailcustomerservice@cardivamedical.com
Phone+1-408-470-7170
Emailcustomerservice@cardivamedical.com
Phone+1-408-470-7170
Emailcustomerservice@cardivamedical.com
Phone+1-408-470-7170
Emailcustomerservice@cardivamedical.com
Phone+1-408-470-7170
Emailcustomerservice@cardivamedical.com
Phone+1-408-470-7170
Emailcustomerservice@cardivamedical.com
Phone+1-408-470-7170
Emailcustomerservice@cardivamedical.com
Phone+1-408-470-7170
Emailcustomerservice@cardivamedical.com
Phone+1-408-470-7170
Emailcustomerservice@cardivamedical.com
Phone+1-408-470-7170
Emailcustomerservice@cardivamedical.com
Phone+1-408-470-7170
Emailcustomerservice@cardivamedical.com
Phone+1-408-470-7170
Emailcustomerservice@cardivamedical.com
Phone+1-408-470-7170
Emailcustomerservice@cardivamedical.com
Phone+1-408-470-7170
Emailcustomerservice@cardivamedical.com
Phone+1-408-470-7170
Emailcustomerservice@cardivamedical.com
Phone+1-408-470-7170
Emailcustomerservice@cardivamedical.com
Phone+1-408-470-7170
Emailcustomerservice@cardivamedical.com
Phone+1-408-470-7170
Emailcustomerservice@cardivamedical.com
Phone+1-408-470-7170
Emailcustomerservice@cardivamedical.com
Phone+1-408-470-7170
Emailcustomerservice@cardivamedical.com
Phone+1-408-470-7170
Emailcustomerservice@cardivamedical.com
Phone+1-408-470-7170
Emailcustomerservice@cardivamedical.com
Phone+1-408-470-7170
Emailcustomerservice@cardivamedical.com
Phone+1-408-470-7170
Emailcustomerservice@cardivamedical.com
Phone+1-408-470-7170
Emailcustomerservice@cardivamedical.com
Phone+1-408-470-7170
Emailcustomerservice@cardivamedical.com
Phone+1-408-470-7170
Emailcustomerservice@cardivamedical.com
Phone+1-408-470-7170
Emailcustomerservice@cardivamedical.com
Phone+1-408-470-7170
Emailcustomerservice@cardivamedical.com
Phone+1-408-470-7170
Emailcustomerservice@cardivamedical.com
Phone+1-408-470-7170
Emailcustomerservice@cardivamedical.com
Phone+1-408-470-7170
Emailcustomerservice@cardivamedical.com
Phone+1-408-470-7170
Emailcustomerservice@cardivamedical.com
Phone+1-408-470-7170
Emailcustomerservice@cardivamedical.com

Device Dimensions

Catheter Gauge7 French
Catheter Gauge6 French
Catheter Gauge7 French
Catheter Gauge6 French
Catheter Gauge7 French
Catheter Gauge6 French
Catheter Gauge7 French
Catheter Gauge6 French
Catheter Gauge7 French
Catheter Gauge6 French
Catheter Gauge7 French
Catheter Gauge6 French
Catheter Gauge7 French
Catheter Gauge6 French
Catheter Gauge7 French
Catheter Gauge6 French
Catheter Gauge7 French
Catheter Gauge6 French
Catheter Gauge7 French
Catheter Gauge6 French
Catheter Gauge7 French
Catheter Gauge6 French
Catheter Gauge7 French
Catheter Gauge6 French
Catheter Gauge7 French
Catheter Gauge6 French
Catheter Gauge7 French
Catheter Gauge6 French
Catheter Gauge7 French
Catheter Gauge6 French
Catheter Gauge7 French
Catheter Gauge6 French
Catheter Gauge7 French
Catheter Gauge6 French
Catheter Gauge7 French
Catheter Gauge6 French
Catheter Gauge7 French
Catheter Gauge6 French
Catheter Gauge7 French
Catheter Gauge6 French
Catheter Gauge7 French
Catheter Gauge6 French
Catheter Gauge7 French
Catheter Gauge6 French
Catheter Gauge7 French
Catheter Gauge6 French
Catheter Gauge7 French
Catheter Gauge6 French
Catheter Gauge7 French
Catheter Gauge6 French
Catheter Gauge7 French
Catheter Gauge6 French
Catheter Gauge7 French
Catheter Gauge6 French
Catheter Gauge7 French
Catheter Gauge6 French
Catheter Gauge7 French
Catheter Gauge6 French
Catheter Gauge7 French
Catheter Gauge6 French
Catheter Gauge7 French
Catheter Gauge6 French
Catheter Gauge7 French
Catheter Gauge6 French
Catheter Gauge7 French
Catheter Gauge6 French
Catheter Gauge7 French
Catheter Gauge6 French
Catheter Gauge7 French
Catheter Gauge6 French
Catheter Gauge7 French
Catheter Gauge6 French
Catheter Gauge7 French
Catheter Gauge6 French
Catheter Gauge7 French
Catheter Gauge6 French
Catheter Gauge7 French
Catheter Gauge6 French
Catheter Gauge7 French
Catheter Gauge6 French

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM729700580I0 [Primary]
HIBCCM729700580I1 [Package]
Contains: M729700580I0
Package: 5-pk carton [5 Units]
In Commercial Distribution
HIBCCM729700580I3 [Package]
Contains: M729700580I0
Package: 1-pk carton [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MGBDevice, Hemostasis, Vascular

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number7
Public Version Date2021-02-05
Device Publish Date2015-12-29

Devices Manufactured by CARDIVA MEDICAL, INC.

M729700500DX1 - Cardiva VASCADE 5F VCS2021-02-05 The VASCADE VCS is intended to seal the femoral arterial access site at the completion of an endovascular procedure. The system
M729700580I1 - Cardiva VASCADE 6/7F VCS2021-02-05The VASCADE VCS is intended to seal the femoral arterial access site at the completion of an endovascular procedure. The system is designed to deliver a resorbable Collagen Patch, extra-vascularly, at the arteriotomy site to aid in achieving hemostasis. For use in 6F & 7F introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm.
M729700580I1 - Cardiva VASCADE 6/7F VCS2021-02-05 The VASCADE VCS is intended to seal the femoral arterial access site at the completion of an endovascular procedure. The system
M729800612C2 - Cardiva VASCADE MVP VVCS 6-12F2021-02-05 The VASCADE MVP Venous Vascular Closure System (VVCS) is intended to seal the femoral venous access site at the completion of ca
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