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A-V Fistula Needle

by Bd Becton Dickinson Vacutainer Systems Preanalytic 510(k)

Active United States

510(k) K781331

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK781331 Date17 Aug 1978ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DJC
Device Class
Class II
Regulation
21 CFR Part 862.3610
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The A-V Fistula Needle is a medical device designed for accessing arteriovenous (A-V) fistulas, which are surgically created connections between an artery and a vein. It is intended to facilitate blood sampling or infusion procedures in patients with chronic kidney disease or other conditions requiring repeated vascular access.

This device is supplied sterile and intended for single-use. It is classified as a Class 2 medical device under FDA regulation 862.3610 and was cleared via the 510(k) pathway (K781331) in 1978. The needle is used in clinical settings such as hospitals and dialysis centers, where precise vascular access is required. No additional regulatory status beyond the stated FDA clearance is implied.

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