PMA P120016S026

Device: Cardiva VASCADE Vascular Closure System (VCS)
Applicant: Cardiva Medical, Inc.
PMA number: P120016
Supplement: S026
Product code: MGB
Decision date: 2019-02-05
Classification: Device, Hemostasis, Vascular
Generic name: Device, hemostasis, vascular
Approval order statement: Approval for changing your California headquarters facility to 1615 Wyatt Dr., Santa Clara, California, for the VASCADE Vascular Closure System (VCS) 700-500DX, 70-580I, 800-612C devices.

Current openFDA PMA Record#

Device: Cardiva VASCADE Vascular Closure System (VCS)
Applicant: Cardiva Medical, Inc.
PMA number: P120016
Supplement: S026
Product code: MGB
Generic name: Device, hemostasis, vascular
Decision date: 2019-02-05
Decision code: APPR
Date received: 2018-11-23
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for changing your California headquarters facility to 1615 Wyatt Dr., Santa Clara, California, for the VASCADE Vascular Closure System (VCS) 700-500DX, 70-580I, 800-612C devices.