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FDA 510(k)

PRO-GUIDE

K-Number: K911747 · 1991-09-18

ApplicantAmerican Interventional Technology
Decision Date1991-09-18
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PRO-GUIDE is the device name listed in this FDA 510(k) record. The listed applicant is American Interventional Technology. It received FDA 510(k) clearance on 1991-09-18 under 510(k) number K911747. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRO-GUIDE?

PRO-GUIDE is a medical device that received FDA 510(k) clearance on 1991-09-18. The listed applicant is American Interventional Technology. The 510(k) number is K911747.

When did PRO-GUIDE receive FDA 510(k) clearance?

PRO-GUIDE received FDA 510(k) clearance on 1991-09-18, under 510(k) number K911747.

Who is the listed applicant for PRO-GUIDE?

The FDA 510(k) record lists American Interventional Technology as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRO-GUIDE?

The FDA product code for PRO-GUIDE is DQY.

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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.

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