AccessGUDID - DEVICE: Cardiva VASCADE 6/7F VCS (M729700580I0)

GUDID

Device Identifier (DI) Information

Brand Name: Cardiva VASCADE 6/7F VCS
Version or Model: 700-580I
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CARDIVA MEDICAL, INC.

Primary DI Number: M729700580I0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 128112195 *Terms of Use

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 6F & 7F introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MGB	Device, Hemostasis, Vascular

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P120016	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 15 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 7 French
Catheter Gauge: 6 French

Device Record Status

Public Device Record Key: a2fb250d-3cd4-4851-8248-0f9a5d5f26f0
Public Version Date: May 13, 2024
Public Version Number: 10
DI Record Publish Date: December 29, 2015