# K993118: Bioteque a.V. Fistula Needle Set

- Pathway: 510(k) (Traditional)
- Applicant: Bioteque Corp.
- Decided: Dec 17, 1999 after 88 days
- Product code: FIE (Needle, Fistula)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K891062 (1989). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K891062: Terumo AV Fistula Needle Set, Terumo Medical Corp. (1989) Summary page 1.

## Indications for use
Bioteque A.V. fistula needle set consist of a fistula needle which inserted into the site of patient’s vessel to obtain blood flow adequate to pass through the dialyser and the reinfusion of dialysed blood back to patient via the fistula needle during hemodialysis.

Source page: https://510kreport.com/device/K993118
Methodology: https://510kreport.com/methodology