Cardiva VASCADE 5F VCS

GUDID M729700500DX1

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 5F introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm.

CARDIVA MEDICAL, INC.

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• Primary Device ID: M729700500DX1
• NIH Device Record Key: 1a7a7400-f3e3-43b2-b217-ad7187ba4e33
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cardiva VASCADE 5F VCS
• Version Model Number: 700-500DX
• Company DUNS: 128112195
• Company Name: CARDIVA MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1-408-470-7170
• Email: customerservice@cardivamedical.com
• Phone: +1-408-470-7170
• Email: customerservice@cardivamedical.com
• Phone: +1-408-470-7170
• Email: customerservice@cardivamedical.com
• Phone: +1-408-470-7170
• Email: customerservice@cardivamedical.com
• Phone: +1-408-470-7170
• Email: customerservice@cardivamedical.com
• Phone: +1-408-470-7170
• Email: customerservice@cardivamedical.com
• Phone: +1-408-470-7170
• Email: customerservice@cardivamedical.com
• Phone: +1-408-470-7170
• Email: customerservice@cardivamedical.com
• Phone: +1-408-470-7170
• Email: customerservice@cardivamedical.com
• Phone: +1-408-470-7170
• Email: customerservice@cardivamedical.com
• Phone: +1-408-470-7170
• Email: customerservice@cardivamedical.com
• Phone: +1-408-470-7170
• Email: customerservice@cardivamedical.com
• Phone: +1-408-470-7170
• Email: customerservice@cardivamedical.com
• Phone: +1-408-470-7170
• Email: customerservice@cardivamedical.com
• Phone: +1-408-470-7170
• Email: customerservice@cardivamedical.com
• Phone: +1-408-470-7170
• Email: customerservice@cardivamedical.com
• Phone: +1-408-470-7170
• Email: customerservice@cardivamedical.com
• Phone: +1-408-470-7170
• Email: customerservice@cardivamedical.com
• Phone: +1-408-470-7170
• Email: customerservice@cardivamedical.com
• Phone: +1-408-470-7170
• Email: customerservice@cardivamedical.com
• Phone: +1-408-470-7170
• Email: customerservice@cardivamedical.com
• Phone: +1-408-470-7170
• Email: customerservice@cardivamedical.com
• Phone: +1-408-470-7170
• Email: customerservice@cardivamedical.com
• Phone: +1-408-470-7170
• Email: customerservice@cardivamedical.com
• Phone: +1-408-470-7170
• Email: customerservice@cardivamedical.com
• Phone: +1-408-470-7170
• Email: customerservice@cardivamedical.com
• Phone: +1-408-470-7170
• Email: customerservice@cardivamedical.com
• Phone: +1-408-470-7170
• Email: customerservice@cardivamedical.com
• Phone: +1-408-470-7170
• Email: customerservice@cardivamedical.com
• Phone: +1-408-470-7170
• Email: customerservice@cardivamedical.com
• Phone: +1-408-470-7170
• Email: customerservice@cardivamedical.com
• Phone: +1-408-470-7170
• Email: customerservice@cardivamedical.com
• Phone: +1-408-470-7170
• Email: customerservice@cardivamedical.com
• Phone: +1-408-470-7170
• Email: customerservice@cardivamedical.com
• Phone: +1-408-470-7170
• Email: customerservice@cardivamedical.com
• Phone: +1-408-470-7170
• Email: customerservice@cardivamedical.com
• Phone: +1-408-470-7170
• Email: customerservice@cardivamedical.com
• Phone: +1-408-470-7170
• Email: customerservice@cardivamedical.com
• Phone: +1-408-470-7170
• Email: customerservice@cardivamedical.com
• Phone: +1-408-470-7170
• Email: customerservice@cardivamedical.com

Device Dimensions

• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M729700500DX0 [Primary]
HIBCC	M729700500DX1 [Package]; Contains: M729700500DX0; Package: 5-pk carton [5 Units]; In Commercial Distribution
HIBCC	M729700500DX3 [Package]; Contains: M729700500DX0; Package: 1-pk carton [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P120016

FDA Product Code

• MGB: Device, Hemostasis, Vascular

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 7
• Public Version Date: 2021-02-05
• Device Publish Date: 2015-12-29

Devices Manufactured by CARDIVA MEDICAL, INC.

• M729700500DX1 - Cardiva VASCADE 5F VCS: 2021-02-05The 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 5F introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm.
• M729700500DX1 - Cardiva VASCADE 5F VCS: 2021-02-05 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 VCS: 2021-02-05 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 6-12F: 2021-02-05 The VASCADE MVP Venous Vascular Closure System (VVCS) is intended to seal the femoral venous access site at the completion of ca