BIOTEQUE A.V. FISTULA NEEDLE SET— 510(k) K993118

Clearance details

Applicant

Bioteque Corp.

Product code

Code FIE

Device class

Class 2

Regulation

21 CFR 876.5540

Advisory panel

Gastroenterology, Urology

Date received

1999-09-20

Decision date

1999-12-17

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Flaggstaff, AZ, US

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Death

2

Total

2

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 →