PMA P250015
- Device
- PerQseal® Elite Vascular Closure Device
- Applicant
- Vivasure Medical , Ltd.
- PMA number
- P250015
- Product code
- MGB
- Decision date
- 2026-10-16
- Classification
- Cardiovascular
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- Approval for the PerQSeal Elite Vascular Closure Device. The device is indicated for the percutaneous closure of common femoral arteriotomies in patients following interventional endovascular catheterization procedures utilizing 14 – 22 F sheaths (arteriotomies up to 26 F).
Current openFDA PMA Record#
- Device
- PerQseal® Elite Vascular Closure Device
- Applicant
- Vivasure Medical , Ltd.
- PMA number
- P250015
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2026-10-16
- Decision code
- APPR
- Date received
- 2025-06-16
- Approval order statement
- Approval for the PerQSeal Elite Vascular Closure Device. The device is indicated for the percutaneous closure of common femoral arteriotomies in patients following interventional endovascular catheterization procedures utilizing 14 – 22 F sheaths (arteriotomies up to 26 F).