PMA P120016S039

Device: VASCADE MVP XL VVCS Model 800-1014XL
Applicant: Cardiva Medical, Inc.
PMA number: P120016
Supplement: S039
Product code: MGB
Decision date: 2026-03-27
Classification: Cardiovascular
Generic name: Device, hemostasis, vascular
Approval order statement: The VASCADE MVP XL Venous Vascular Closure System (VVCS) Model 800-1014XL is indicated for the percutaneous closure of femoral venous access sites while reducing time to ambulation, total post-procedure time, time to hemostasis, and time to discharge eligibility in patients who have undergone catheter-based procedures utilizing 8 – 14F inner diameter (17F maximum outer diameter) procedural sheaths, with single or multiple access sites in one or both limbs. The VASCADE MVP XL Venous Vascular Closure System (VVCS) Model 800-1014XL is also indicated for enabling same day discharge in patients who have undergone catheter-based cardiac arrhythmia ablation procedures utilizing 8 – 14F inner diameter (17F maximum outer diameter) procedural sheaths, with single or multiple access sites in one or both limbs.

Current openFDA PMA Record#

Device: VASCADE MVP XL VVCS Model 800-1014XL
Applicant: Cardiva Medical, Inc.
PMA number: P120016
Supplement: S039
Product code: MGB
Generic name: Device, hemostasis, vascular
Decision date: 2026-03-27
Decision code: APPR
Date received: 2025-09-30
Supplement type: Panel Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: The VASCADE MVP XL Venous Vascular Closure System (VVCS) Model 800-1014XL is indicated for the percutaneous closure of femoral venous access sites while reducing time to ambulation, total post-procedure time, time to hemostasis, and time to discharge eligibility in patients who have undergone catheter-based procedures utilizing 8 – 14F inner diameter (17F maximum outer diameter) procedural sheaths, with single or multiple access sites in one or both limbs. The VASCADE MVP XL Venous Vascular Closure System (VVCS) Model 800-1014XL is also indicated for enabling same day discharge in patients who have undergone catheter-based cardiac arrhythmia ablation procedures utilizing 8 – 14F inner diameter (17F maximum outer diameter) procedural sheaths, with single or multiple access sites in one or both limbs.