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STARCLOSURE SE Vascular Closure System

by Abbott Vascular Devices

PMA P050007

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None ongoing

2 closed

Documents

PMA P050007↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP050007 Date21 Dec 2005ApprovedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-1202-2017 FDA Class II initiated 10 Feb 2017

    Abbott Vascular is recalling the StarClose SE Vascular Closure System because it may exhibit difficulty or failure to deploy the StarClose SE Clip.

    • Terminated Z-1657-2009 FDA Unclassified (pre-2012) initiated 6 May 2009

    Potential sterility issue. Internal component quarantined for possible contamination, was released for sale after going through sterilization procedure.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

PMA

Trade Name
Starclose Vascular Closure System
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 STARCLOSURE SE Vascular Closure System is a device designed for the percutaneous closure of common femoral artery access sites. It is intended to reduce times to hemostasis, ambulation, and dischargeability in patients who have undergone diagnostic endovascular catheterization procedures utilizing a 5F or 6F procedural sheath.

The device is manufactured by Abbott Vascular Devices and has received FDA PMA approval. It is indicated for use in patients undergoing diagnostic procedures with specific sheath sizes, though specific details regarding sterility, single-use or reusable status, MRI safety, sizes, and storage are not provided in the available data.

Other devices from Abbott Vascular Devices

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 is the STARCLOSURE SE Vascular Closure System used for?

    The STARCLOSURE SE Vascular Closure System is used for the percutaneous closure of common femoral artery access sites following diagnostic endovascular catheterization procedures. It is specifically designed to reduce times to hemostasis, ambulation, and dischargeability in patients who have undergone procedures using a 5F or 6F procedural sheath.

  • What are the regulatory approvals for this device?

    The STARCLOSURE SE Vascular Closure System has received FDA PMA (Premarket Approval) with the approval number P050007. This indicates that the device has been evaluated by the FDA and found to be safe and effective for its intended use in closing femoral artery access sites after diagnostic procedures.

  • Which manufacturer produces the STARCLOSURE SE Vascular Closure System?

    The STARCLOSURE SE Vascular Closure System is manufactured by Abbott Vascular Devices, located in Santa Clara, California. The company is responsible for the production and distribution of this vascular closure device.