GALEO HYDRO AND GALEO HYDRO J-TIP— 510(k) K001736

Substantially Equivalent

Biotronik, Inc.

FDA 510(k) clearance K001736 for GALEO HYDRO AND GALEO HYDRO J-TIP, Substantially Equivalent on 2000-08-02. Applicant: Biotronik, Inc..

Clearance details

Applicant: Biotronik, Inc.
Product code: Code DQX
Advisory panel: Cardiovascular
Date received: 2000-06-07
Decision date: 2000-08-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Lake Oswego, OR, US

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Adverse events under product code DQX

product code DQX

Death: 298
Injury: 4,385
Malfunction: 7,203
Other: 5
Total: 11,891

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.