HSA · registration DE0505258Teleflex MANTA™ Vascular Closure Device
- Registration number
- DE0505258
- Model name
- Manta Depth Locator 14F; Manta Depth Locator 8F; MANTA™ Vascular Closure Device 18F ; MANTA™ Vascular Closure Device 14F
- Model identifier
- 114F; 188F; 2115NE; 2156NE
- Registration date
- December 18, 2020
- Source update date
- December 29, 2025
- Risk class
- Class D
- Product owner
- Teleflex Medical LLC
- Registrant / registration holder
- TELEFLEX MEDICAL ASIA PTE. LTD.
The MANTA device is intended to be used following a large bore percutaneous procedure to close and seal the vascular puncture.The 14F MANTA Vascular Closure Device is for access sites in the femoral artery following the use of 10-14F devices or sheaths (maximum OD of 18F). The 18F MANTA Vascular Closure Device is for access sites in the femoral artery following the use of 15-20F devices or sheaths (maximum OD of 25F).The intended purpose of the Depth Locator and Sheath markings are to determine the depth in which the implant is to be deployed.
- Product owner address
- 3015 Carrington Mill Blvd, Morrisville, NC 27560 USA, United States
- Registrant address
- 83 CLEMENCEAU AVENUE, #05-05-08, UE SQUARE, Singapore 239920
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.