PMA P120016S040

Device: Cardiva, VASCADE Family
Applicant: Cardiva Medical, Inc.
PMA number: P120016
Supplement: S040
Product code: MGB
Decision date: 2026-04-23
Classification: Cardiovascular
Generic name: Device, hemostasis, vascular
Approval order statement: an additional supplier for the collagen plug component of the VASCADE 6/7F (Model 700-580I) and VASCADE MVP Venous Vascular Closure System (VVCS) (Model 800-612C) devices

Current openFDA PMA Record#

Device: Cardiva, VASCADE Family
Applicant: Cardiva Medical, Inc.
PMA number: P120016
Supplement: S040
Product code: MGB
Generic name: Device, hemostasis, vascular
Decision date: 2026-04-23
Decision code: APPR
Date received: 2025-12-30
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: an additional supplier for the collagen plug component of the VASCADE 6/7F (Model 700-580I) and VASCADE MVP Venous Vascular Closure System (VVCS) (Model 800-612C) devices