FDA 510(k)

EVT MARKER BOARD

K-Number: K970608 · 1997-04-21

ApplicantGuidant Cardiac and Vascular Surgery

Decision Date1997-04-21

Product CodeJAA

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

EVT MARKER BOARD is the device name listed in this FDA 510(k) record. The listed applicant is Guidant Cardiac and Vascular Surgery. It received FDA 510(k) clearance on 1997-04-21 under 510(k) number K970608. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EVT MARKER BOARD?

EVT MARKER BOARD is a medical device that received FDA 510(k) clearance on 1997-04-21. The listed applicant is Guidant Cardiac and Vascular Surgery. The 510(k) number is K970608.

When did EVT MARKER BOARD receive FDA 510(k) clearance?

EVT MARKER BOARD received FDA 510(k) clearance on 1997-04-21, under 510(k) number K970608.

Who is the listed applicant for EVT MARKER BOARD?

The FDA 510(k) record lists Guidant Cardiac and Vascular Surgery as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EVT MARKER BOARD?

The FDA product code for EVT MARKER BOARD is JAA.

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Other records listing Guidant Cardiac and Vascular Surgery as applicant

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Official Source

View on FDA Database →

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