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FDA 510(k)

HEARTTRACK QUANTITATIVE CORONARY ANGIOGRAPHY SOFTW

K-Number: K933058 · 1993-09-28

ApplicantHeartware Intl. Corp.
Decision Date1993-09-28
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HEARTTRACK QUANTITATIVE CORONARY ANGIOGRAPHY SOFTW is the device name listed in this FDA 510(k) record. The listed applicant is Heartware Intl. Corp.. It received FDA 510(k) clearance on 1993-09-28 under 510(k) number K933058. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEARTTRACK QUANTITATIVE CORONARY ANGIOGRAPHY SOFTW?

HEARTTRACK QUANTITATIVE CORONARY ANGIOGRAPHY SOFTW is a medical device that received FDA 510(k) clearance on 1993-09-28. The listed applicant is Heartware Intl. Corp.. The 510(k) number is K933058.

When did HEARTTRACK QUANTITATIVE CORONARY ANGIOGRAPHY SOFTW receive FDA 510(k) clearance?

HEARTTRACK QUANTITATIVE CORONARY ANGIOGRAPHY SOFTW received FDA 510(k) clearance on 1993-09-28, under 510(k) number K933058.

Who is the listed applicant for HEARTTRACK QUANTITATIVE CORONARY ANGIOGRAPHY SOFTW?

The FDA 510(k) record lists Heartware Intl. Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEARTTRACK QUANTITATIVE CORONARY ANGIOGRAPHY SOFTW?

The FDA product code for HEARTTRACK QUANTITATIVE CORONARY ANGIOGRAPHY SOFTW is IZI.

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Other records listing Heartware Intl. Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K932410HEARTVIEW(R) CORONARY ANGIOGRAPH DIAGRAM/REPORT SYK933073HEARTTRACE LEFT VENTRICULAR ANALYSIS SOFTWAREK893094HB 1000, BRUGADA ELECTROPHYSIOLOGY SYSTEM

Related Devices (Code: IZI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker EndoscopyK253181SURGIMAGE SIM 1000H Fluorescence Imaging PlatformSurgimage CorporationK243645IC-Flow™ Imaging System 2.0Diagnostic Green GmbHK243077Affirm 800Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)K231986Modus IRSynaptive Medical, Inc.K234090EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)Surgvision GmbH

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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