Cardiva Catalyst II VCS

Basic Information

• Brand Name: Cardiva Catalyst II VCS
• Primary DI: M729500580C0
• Version / Model: 500-580C
• 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: 3
• Public Version Date: 2019-08-23
• Public Version Status: Update
• Public Device Record Key: b135dfbe-1045-42f5-be12-3a6cc28aa018

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

• 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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• 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
DXC	Clamp, Vascular	Cardiovascular	870.4450	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46370	Femoral artery compression system, single-use	An assembly of sterile devices intended to be used in conjunction with manual compression to facilitate haemostasis to the puncture site on a patient having undergone femoral artery catheterization. It typically consists of a dedicated catheter with an elastomeric membrane at the distal tip and a tensioner. The catheter is inserted through the previously placed catheter introducer sheath and, once positioned, the membrane is deployed in the inner lumen of the femoral artery. Tension is applied to keep the membrane against the arteriotomy while the natural mechanisms of haemostasis are enacted. Once haemostasis is achieved, this device is removed. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	M729500580C2	HIBCC	10-pk carton	10	In Commercial Distribution
Primary	M729500580C0	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	7	French
Catheter Gauge	6	French
Catheter Gauge	5	French

Storage Conditions

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