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Cardioseal Septal Occlusion System With Qwikload

by Nmt Medical, Inc.

PMA P000049510(k) K842102

Active United States

PMA 510(k)

Valid until

No expiry

FDA authorization is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMA PMA NumberP000049 Date5 Dec 2001ApprovedStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK842102 Date17 Jul 1984ClearedStatusActive

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  • Withdrawn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 510(k), FDA PMA Active

Specification

510(k) · PMA

Full name
Cardioseal Septal Occlusion System W/Qwik Load
Trade Name
Cardioseal Septal Occlusion System with Qwikload
Generic Name
Transcatheter septal occluder
FDA applicant
Lorad Medical Systems, Inc.
PMA Number
510(k) Number
FDA Product Code
IZH
Device Class
Class II
Regulation
21 CFR Part 892.1710
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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 Cardioseal Septal Occlusion System with Qwikload is a transcatheter septal occluder designed to treat complex ventricular septal defects (VSD). It is intended for use in patients with defects of significant size who are considered at high risk for standard transatrial or transarterial surgical closure due to their anatomical or medical condition.

This system is indicated for patients requiring left or extensive right ventriculotomy, those with failed previous VSD closures, or individuals with multiple apical or anterior muscular VSDs. It is also suitable for patients with posterior apical VSDs covered by trabeculae. The device is authorized for use under FDA PMA and 510k regulatory pathways.

Other devices from Nmt Medical, 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 purpose of the Cardioseal Septal Occlusion System?

    The system is a transcatheter septal occluder used to close complex ventricular septal defects in patients who are at high risk for traditional surgical intervention.

  • Which patients are candidates for this device?

    Candidates include patients with significant VSDs who have complex anatomical conditions, such as multiple muscular defects, posterior apical defects covered by trabeculae, or those who have previously undergone a failed surgical closure.

  • Why is this device used instead of standard surgery?

    It is indicated for patients whose overall medical condition or specific anatomical factors make them high-risk candidates for standard transatrial or transarterial surgical procedures.