Bionics Arterial/Venous Fistula Needle
by Cordis Corp.
510(k) K801354
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK801354 | Date8 Jul 1980 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KOC
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5820
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Bionics Arterial/Venous Fistula Needle is a needle, vascular access designed for hemodialysis procedures. It is specifically engineered to access arteriovenous fistulas, enabling reliable blood withdrawal and return during dialysis treatments. Constructed from biocompatible materials, it minimizes patient discomfort and reduces the risk of complications such as clotting or allergic reactions during insertion.
This device is supplied as a single-use, sterile product and is intended for use in clinical hemodialysis settings. It adheres to FDA clearance under 510(k) K801354, classified under regulation 876.5820 for blood circuit accessories. The needle features a silicone-coated design and ergonomic wings to enhance handling and precision. Storage requires adherence to standard sterile medical device protocols, and its use is governed by regulatory compliance with hemodialysis access standards.
Other devices from Cordis US Corp.
Questions
AI-generated answers, 1 Oct 2026
What is the Bionics Arterial/Venous Fistula Needle used for?
The Bionics Arterial/Venous Fistula Needle is specifically engineered for hemodialysis procedures to access arteriovenous fistulas. It enables safe and efficient blood withdrawal and return during dialysis treatments, minimizing patient discomfort and reducing complications like clotting or allergic reactions. Its design ensures precise access, which is critical for maintaining effective dialysis therapy.
Is the Bionics Arterial/Venous Fistula Needle single-use or reusable?
The Bionics Arterial/Venous Fistula Needle is supplied as a single-use device. This design choice ensures sterility and safety for each patient, reducing the risk of cross-contamination or infection between uses. Single-use devices are standard in clinical hemodialysis settings to uphold rigorous infection control protocols.
What materials is the needle constructed from, and how does it reduce patient discomfort?
The Bionics Arterial/Venous Fistula Needle is constructed from biocompatible materials, which are carefully selected to minimize adverse reactions in patients. Its silicone-coated design further reduces friction during insertion, lowering discomfort. Additionally, the ergonomic wings on the needle enhance handling precision, allowing clinicians to perform access with greater control and ease.
How should the Bionics Arterial/Venous Fistula Needle be stored?
The needle must be stored according to standard sterile medical device protocols. This includes maintaining its sterile packaging until immediate use and ensuring it is kept in a clean, dry environment protected from contamination. Proper storage is essential to preserve sterility and functionality, adhering to regulatory compliance for hemodialysis access devices.
What regulatory approval does the Bionics Arterial/Venous Fistula Needle hold?
The Bionics Arterial/Venous Fistula Needle holds FDA clearance under the 510(k) submission K801354, classified under regulation 876.5820 for blood circuit accessories. This clearance confirms its substantial equivalence to a predicate device and compliance with U.S. regulatory standards for hemodialysis access. The device is governed by these approvals to ensure safety and efficacy in clinical use.