Bioteque A.V. Fistula Needle Set

by Bioteque Corp. 510(k)

Active United States

510(k) K993118

Regulatory status

as of 26 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK993118	Date17 Dec 1999Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k)

510(k) Number: K993118
FDA Product Code: FIE

Regulation: 21 CFR Part 876.5540
Advisory Committee: Gastroenterology, Urology
FDA Decision: SESE Substantially Equivalent

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