Evt Marker Board

FDA 510(k) K970608 · Guidant Cardiac and Vascular Surgery

Substantially Equivalent

510(k) numberK970608

Submission

Device name
Evt Marker Board
Applicant
Guidant Cardiac and Vascular Surgery
Menlo Park, CA, US
Received
February 18, 1997
Decision date
April 21, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JAA – System, X-Ray, Fluoroscopic, Image-Intensified
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1650
Specialty
Radiology

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More from Omega Medical Imaging, LLC

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K002676Endovance Dualpass Tear-Away Sheath IntroducerDYB · Traditional 10/30/2000SE
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Questions and answers

When was Evt Marker Board cleared by the FDA?

Evt Marker Board (K970608) received a 510(k) decision of Substantially Equivalent on April 21, 1997, 62 days after the submission was received.

What is the product code of K970608?

The FDA product code is JAA – System, X-Ray, Fluoroscopic, Image-Intensified, a Class II (moderate risk) device regulated under 21 CFR 892.1650.