FDA 510(k)

EVT ANGIOSCALE ANGIOGRAPHIC CATHETER

K-Number: K970469 · 1997-05-08

ApplicantGuidant Cardiac and Vascular Surgery

Decision Date1997-05-08

Product CodeDQO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

EVT ANGIOSCALE ANGIOGRAPHIC CATHETER 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 1997-05-08 under 510(k) number K970469. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EVT ANGIOSCALE ANGIOGRAPHIC CATHETER?

EVT ANGIOSCALE ANGIOGRAPHIC CATHETER is a medical device that received FDA 510(k) clearance on 1997-05-08. The listed applicant is Guidant Cardiac and Vascular Surgery. The 510(k) number is K970469.

When did EVT ANGIOSCALE ANGIOGRAPHIC CATHETER receive FDA 510(k) clearance?

EVT ANGIOSCALE ANGIOGRAPHIC CATHETER received FDA 510(k) clearance on 1997-05-08, under 510(k) number K970469.

Who is the listed applicant for EVT ANGIOSCALE ANGIOGRAPHIC CATHETER?

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 ANGIOSCALE ANGIOGRAPHIC CATHETER?

The FDA product code for EVT ANGIOSCALE ANGIOGRAPHIC CATHETER is DQO.

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Other records listing Guidant Cardiac and Vascular Surgery as applicant

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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.