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FDA 510(k)

FASGUIDE CATHETER

K-Number: K935597 · 1994-10-18

ApplicantTarget Therapeutics
Decision Date1994-10-18
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FASGUIDE CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Target Therapeutics. It received FDA 510(k) clearance on 1994-10-18 under 510(k) number K935597. 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 FASGUIDE CATHETER?

FASGUIDE CATHETER is a medical device that received FDA 510(k) clearance on 1994-10-18. The listed applicant is Target Therapeutics. The 510(k) number is K935597.

When did FASGUIDE CATHETER receive FDA 510(k) clearance?

FASGUIDE CATHETER received FDA 510(k) clearance on 1994-10-18, under 510(k) number K935597.

Who is the listed applicant for FASGUIDE CATHETER?

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 FASGUIDE CATHETER?

The FDA product code for FASGUIDE CATHETER is DQY.

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Other records listing Target Therapeutics as applicant

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Related Devices (Code: DQY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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