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510(k) K972229

IMAGEVIEW CORONARY ANGIOGRAPHY DISPLAY AND REVIEW SYSTEM by Heartware, Inc. — Product Code IZI

K972229 is an FDA 510(k) premarket notification submitted by Heartware, Inc. for the device "IMAGEVIEW CORONARY ANGIOGRAPHY DISPLAY AND REVIEW SYSTEM". The FDA issued a decision of Substantially Equivalent on October 16, 1997. The device falls under product code IZI (System, X-Ray, Angiographic), a Class II device regulated under 21 CFR 892.1600.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 1997
Date Received
June 13, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Angiographic
Device Class
Class II
Regulation Number
892.1600
Review Panel
RA
Submission Type

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FDA data resources