Heartview(R) Coronary Angiograph Diagram/Report Sy

FDA 510(k) K932410 · Heartware Intl. Corp.

Substantially Equivalent

510(k) numberK932410

Submission

Device name
Heartview(R) Coronary Angiograph Diagram/Report Sy
Applicant
Heartware Intl. Corp.
North Attleboro, MA, US
Received
May 18, 1993
Decision date
December 13, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
IZI – System, X-Ray, Angiographic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1600
Specialty
Radiology

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More from Surgvision GmbH

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K933073Hearttrace Left Ventricular Analysis SoftwareIZI · Traditional 10/07/1993SE
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Questions and answers

When was Heartview(R) Coronary Angiograph Diagram/Report Sy cleared by the FDA?

Heartview(R) Coronary Angiograph Diagram/Report Sy (K932410) received a 510(k) decision of Substantially Equivalent on December 13, 1993, 209 days after the submission was received.

What is the product code of K932410?

The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.