Cardiva VASCADE 5F VCS

Basic Information

• Brand Name: Cardiva VASCADE 5F VCS
• Primary DI: M729700500DX0
• Version / Model: 700-500DX
• Company Name: CARDIVA MEDICAL, INC.
• Labeler DUNS: 128112195
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-12-29
• Public Version: 9
• Public Version Date: 2023-06-27
• Public Version Status: Update
• Public Device Record Key: 1a7a7400-f3e3-43b2-b217-ad7187ba4e33

Device Description

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 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	M729700500DX1	HIBCC	5-pk carton	5	In Commercial Distribution
Primary	M729700500DX0	HIBCC
Package	M729700500DX3	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	000

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	5	French

Storage Conditions

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