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MANTA Vascular Closure Device

by Teleflex Medical, LLC

PMA P180025

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

PMA P180025↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP180025 Date1 Feb 2019ApprovedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Generic Name
Device, hemostasis, vascular
PMA Number
FDA Product Code
MGB
Device Class
Class III
Advisory Committee
Cardiovascular
FDA Decision
APPR Approved

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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

Supplied by Teleflex Medical, LLC, the device is a single-use implant authorized under FDA PMA (P180025). It is intended for use in cardiovascular procedures and is not MRI conditional unless explicitly stated in labeling.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What sizes of the MANTA Vascular Closure Device are available?

    The MANTA Vascular Closure Device is available in 14F and 18F sizes, as specified in the approval documentation for closure of femoral arterial access sites following use of corresponding device or sheath sizes.

  • Is the MANTA Vascular Closure Device reusable?

    No, the MANTA Vascular Closure Device is a single-use implant and is not intended for reuse, as indicated by its classification as a vascular hemostasis device designed for one-time deployment.

  • What regulatory authorization does the MANTA Vascular Closure Device have?

    The MANTA Vascular Closure Device has received FDA Premarket Approval (PMA) under application number P180025, with approval granted on February 1, 2019.