Skip to content

Quickseal Femoral Arterial Closure System

by Sub-Q, Inc.

PMA P010049

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

PMA P010049↗

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 NumberP010049 Date25 Mar 2002ApprovedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

PMA

Full name
Quickseal II Arterial Closure System
Trade Name
Quickseal Femoral Arterial 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 Quickseal Femoral Arterial Closure System is a vascular hemostasis device designed for the extravascular closure of femoral artery access sites. It functions by delivering Gelfoam to the puncture site to facilitate the sealing process.

This system is indicated for use in patients who have undergone diagnostic or interventional procedures using 8 French or smaller procedural sheaths. By utilizing this device, clinicians can reduce the time required to achieve hemostasis, decrease time to ambulation, and shorten the time to hospital discharge eligibility.

Other devices from Sub-Q, Inc.

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 primary function of the Quickseal Femoral Arterial Closure System?

    The system is designed for the extravascular closure of femoral artery access sites by delivering Gelfoam to the puncture site to achieve hemostasis.

  • Which patient procedures is this device indicated for?

    It is indicated for patients who have undergone diagnostic or interventional procedures that utilized procedural sheaths of 8 French or smaller.

  • How does the Quickseal system benefit clinical workflow?

    The device reduces the time required to achieve hemostasis and ambulation, which in turn reduces the time to eligibility for hospital discharge following diagnostic or interventional procedures.