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Gruntzig Dilaca Balloon Dilatation Catheters

by Medtronic, Ireland

PMA P790017

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 P790017↗

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 1 supplement NumberP790017 Date27 Dec 1982ApprovedStatusActive

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  • Withdrawn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

Trade Name
Usci Gruntzig Dilaca Catheter
Generic Name
Catheters, transluminal coronary angioplasty, percutaneous
PMA Number
FDA Product Code
LOX
Device Class
Class II
Regulation
21 CFR Part 870.5100
Advisory Committee
Cardiovascular
FDA Decision
APPR Approved
PMA Supplement
S005

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 Grüntzig Dilaca Balloon Dilatation Catheters are percutaneous transluminal coronary angioplasty catheters designed for the dilation of stenotic coronary arteries. These devices utilize an inflatable balloon to mechanically widen narrowed or obstructed arterial segments, restoring blood flow and improving myocardial perfusion.

These catheters are supplied as single-use medical devices and are intended for use in catheterization laboratories under fluoroscopic guidance. They are regulated under FDA Premarket Approval (PMA) and fall under device classification II (LOX). Sterility and specific sizes are maintained as per manufacturer specifications, with no indication of MRI compatibility or reusable applications in the regulatory data.

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