PMA
P120016: VASCADE VASCULAR CLOSURE SYSTEM
FDA PMA · Device, hemostasis, vascular · Cardiva Medical, Inc.
Key facts
| PMA number | P120016 |
|---|---|
| Trade name | VASCADE VASCULAR CLOSURE SYSTEM |
| Generic name | Device, hemostasis, vascular |
| Applicant | Cardiva Medical, Inc. |
| Owner/operator | CARDIVA MEDICAL, INC. |
| Product code | MGB |
| Approval date | Jan 31, 2013 |
| Docket number | 13M-0592 |
| Notice date | May 17, 2013 |
| Establishment registration | 3011469355 |
| FEI number | 3011469355 |
At a glance
- 10–99 Supplements
- Sep 10, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: