Bioteque A.V. Fistula Needle Set with Safety Flex

by Bioteque Corp. 510(k)

Active United States

510(k) K032292

Regulatory status

as of 26 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK032292	Date22 Mar 2004Cleared	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Withdrawn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: K032292
FDA Product Code: FOZ

Device Class: Class II
Regulation: 21 CFR Part 880.5200
Advisory Committee: General Hospital
FDA Decision: SESE Substantially Equivalent

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