PerQseal® Elite Vascular Closure Device
Vivasure Medical , Ltd. · Device, hemostasis, vascular · Cardiovascular
Open FDA's page for this record- PMA number
- P250015
- Applicant
- Vivasure Medical , Ltd.
- Street 1
- Parkmore Business Park W.
- City
- Galway
- Zip
- H91 V3KP
- Generic name
- Device, hemostasis, vascular
- Trade name
- PerQseal® Elite Vascular Closure Device
- Product code
- MGB
- Advisory committee
- CV
- Advisory committee description
- Cardiovascular
- Expedited review flag
- N
- Date received
- 2025-06-16
- Decision date
- 2026-10-16
- Decision code
- APPR
- Ao 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).
- Harmonized identifiers (openFDA)
- Device name
- Device, Hemostasis, Vascular
- Medical specialty description
- Unknown
- Device class
- 3
- Registration number
- 3005718570, 3003898360, 3008307705, 3012102437, 3015542130, 2183744, 3012977275, 1226183, 3004939290, 2243441, 1423662, 1118880, 3005334138, 2134812, 9616099, 1016427, 2024168, 3011469355, 3013394970, 3015145497, 3011137372, 2953359, 1721686, 3009984513, 3007766601, 3002907620, 2246552, 2022435, 1649518, 3008102042, 3004091615, 2029275, 3012448339, 2939561, 2011171, 3002807314
- FEI number
- 3005718570, 3003898360, 3008307705, 3012102437, 3010142363, 3015542130, 3003528016, 2183744, 3012977275, 3000215273, 2243441, 1000306431, 1118880, 3005334138, 1016427, 2024168, 3011469355, 3013394970, 3015145497, 3002924544, 1721686, 3009984513, 3007766601, 3002827704, 3002907620, 2246552, 3002757549, 2022435, 3004635528, 3001236277, 3004091615, 3000215205, 3012448339, 3005747797, 2011171, 3002807314