MANTA Vascular Closure Device

FDA premarket approval P180025 · Device, hemostasis, vascular

PMA numberP180025

Approval

Applicant
Teleflex Medical, LLC
Received
July 9, 2018
Decision date
February 1, 2019 (APPR)
Supplements
14, latest April 23, 2026
Product code
MGB – Device, Hemostasis, Vascular

Official FDA PMA record

Approval order statement

Approval for the 14F MANTA Vascular Closure Device. The device is indicated for closure of femoral arterial access sites following the use of 10-14F devices or sheaths (maximum OD/profile of 18F), and the 18F MANTA Vascular Closure Device is indicated for closure of femoral arterial access sites following the use of 15-18F devices or sheaths (maximum OD/profile of 25F).