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FDA 510(k)

GUIDER-22

K-Number: K914031 · 1992-02-11

ApplicantTarget Therapeutics
Decision Date1992-02-11
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GUIDER-22 is the device name listed in this FDA 510(k) record. The listed applicant is Target Therapeutics. It received FDA 510(k) clearance on 1992-02-11 under 510(k) number K914031. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GUIDER-22?

GUIDER-22 is a medical device that received FDA 510(k) clearance on 1992-02-11. The listed applicant is Target Therapeutics. The 510(k) number is K914031.

When did GUIDER-22 receive FDA 510(k) clearance?

GUIDER-22 received FDA 510(k) clearance on 1992-02-11, under 510(k) number K914031.

Who is the listed applicant for GUIDER-22?

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

What is the FDA product code for GUIDER-22?

The FDA product code for GUIDER-22 is DQX.

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Related Devices (Code: DQX)

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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.

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