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FDA 510(k)

GALEO HYDRO AND GALEO HYDRO J-TIP

K-Number: K001736 · 2000-08-02

ApplicantBiotronik, Inc.
Decision Date2000-08-02
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GALEO HYDRO AND GALEO HYDRO J-TIP is the device name listed in this FDA 510(k) record. The listed applicant is Biotronik, Inc.. It received FDA 510(k) clearance on 2000-08-02 under 510(k) number K001736. 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 GALEO HYDRO AND GALEO HYDRO J-TIP?

GALEO HYDRO AND GALEO HYDRO J-TIP is a medical device that received FDA 510(k) clearance on 2000-08-02. The listed applicant is Biotronik, Inc.. The 510(k) number is K001736.

When did GALEO HYDRO AND GALEO HYDRO J-TIP receive FDA 510(k) clearance?

GALEO HYDRO AND GALEO HYDRO J-TIP received FDA 510(k) clearance on 2000-08-02, under 510(k) number K001736.

Who is the listed applicant for GALEO HYDRO AND GALEO HYDRO J-TIP?

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

What is the FDA product code for GALEO HYDRO AND GALEO HYDRO J-TIP?

The FDA product code for GALEO HYDRO AND GALEO HYDRO J-TIP is 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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