Cardiva VASCADE MVP VVCS 6-12F

Basic Information

• Brand Name: Cardiva VASCADE MVP VVCS 6-12F
• Primary DI: M729800612C0
• Version / Model: 800-612C
• Company Name: CARDIVA MEDICAL, INC.
• Labeler DUNS: 128112195
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-11-28
• Public Version: 6
• Public Version Date: 2023-06-27
• Public Version Status: Update
• Public Device Record Key: 96eabb31-a160-483e-87d4-4657e4757361

Device Description

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 Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MGB	Device, Hemostasis, Vascular	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
60710	Femoral artery closure plug/patch, collagen	An implantable, bioabsorbable device designed for haemostasis/closure of a puncture site, through pressure/compression, on a patient having undergone femoral artery catheterization; it is intended as an alternative to manual compression or surgical techniques to reduce the time to haemostasis. It consists of an animal-derived collagen plug that is implanted using an included delivery device (e.g., guidewire, hand-held delivery unit) onto the extravascular surface of the femoral artery access site (top of arteriotomy site), and may be held in place with an included synthetic, bioabsorbable patch/anchor/suture to achieve haemostasis.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	M729800612C2	HIBCC		10	In Commercial Distribution
Primary	M729800612C0	HIBCC
Package	M729800612C1	HIBCC		5	In Commercial Distribution
Package	M729800612C3	HIBCC	1-pk carton	1	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P120016	024

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Catheter Gauge: 6 to 12 French

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 25 Degrees Celsius