AccessGUDID - DEVICE: Cardiva Catalyst II VCS (M729500580C0)

GUDID

Device Identifier (DI) Information

Brand Name: Cardiva Catalyst II VCS
Version or Model: 500-580C
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: CARDIVA MEDICAL, INC.

Primary DI Number: M729500580C0
Issuing Agency: HIBCC
Commercial Distribution End Date: February 22, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 128112195 *Terms of Use

Device Description: The Cardiva Catalyst™ II consists of a sterile disposable Catalyst II Wire and a sterile disposable Catalyst Clip. The Cardiva Catalyst II System is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The Cardiva Catalyst II is indicated for use in patients undergoing diagnostic and/or interventional femoral artery catheterization procedures, using 5F, 6F or 7F introducer sheaths.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
63107	Femoral artery medicated closure set	A collection of hand-operated instruments, which includes a pharmaceutical agent, intended for the percutaneous closure of a femoral artery or vein puncture site, following a catheterization procedure, in patients using an anticoagulant medication (e.g., heparin). The collection typically consists of a catheter/sheath which elutes the pharmaceutical agent, intended to locally reverse the effect of the anticoagulant, and a haemostatic plug intended to be temporarily placed within the artery; implantable devices are not included. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXC	Clamp, Vascular

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
Catheter Gauge: 5 French

Device Record Status

Public Device Record Key: b135dfbe-1045-42f5-be12-3a6cc28aa018
Public Version Date: March 04, 2025
Public Version Number: 4
DI Record Publish Date: December 29, 2015