# K013037: Excel a.V Fisutal Needle Set

- Pathway: 510(k) (Traditional)
- Applicant: Exelint Intl. Co.
- Decided: Dec 7, 2001 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K171505: Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series) (2018), 0 descendants of its own

## Indications for use
THIS DEVICE IS AN A.V. FISTULA NEEDLE SET PART OF EXTRACORPORIAL ARTIFICAL KIDNEY SYSTEM FOR THE TREATMENT OF PATIENTS WITH RENAL FAILURE TO PROVIDE ACCESS TO THE PATIENT'S BLOOD VESSEL FOR HEMODIALYSIS.

Source page: https://510kreport.com/device/K013037
Methodology: https://510kreport.com/methodology