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Heartview Coronary Angiograph Diagram/Report System

by Heartware Intl. Corp.

510(k) K932410

Active United States

510(k)

Valid until

No expiry

510(k) clearance 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), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK932410 Date13 Dec 1993ClearedStatusActive

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  • Withdrawn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) Active

Specification

510(k)

Full name
Heartview(R) Coronary Angiograph Diagram/Report Sy
510(k) Number
FDA Product Code
IZI
Device Class
Class II
Regulation
21 CFR Part 892.1600
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 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 Heartview Coronary Angiograph Diagram/Report System is an X-Ray, Angiographic system used in radiology. It is designed to provide a diagram and report of coronary angiography procedures.

The system is supplied as a single unit and is intended for use in a clinical setting. It has been assigned a product code of IZI and a regulation number of 892.1600. The system has received FDA 510K clearance, with the K number being K932410.

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