Modified Dual Lumen Needle
by Quinton, Inc. 510(k)
Active
510(k) K864629
Overview
The Modified Dual Lumen Needle is a Set, Dialysis, Single Needle (Co-Axial Flow) device, as defined by its classification name and medical specialty in Gastroenterology and Urology. It is designed for use in dialysis procedures requiring co-axial flow through a single needle with dual lumens.
This device received FDA 510(k) clearance (K864629) on December 16, 1986, following a traditional review process. It is classified as a Class II medical device under regulation number 876.5540, with product code LBW, and was determined to be substantially equivalent to a predicate device. The device is supplied by Quinton, Inc., located in Seattle, WA.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK864629 | Date16 Dec 1986 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- LBW
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5540
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Quinton, Inc.
Questions
What is the Modified Dual Lumen Needle used for?
The Modified Dual Lumen Needle is designed for use in dialysis procedures requiring co-axial flow through a single needle with dual lumens, as defined by its classification as a Set, Dialysis, Single Needle (Co-Axial Flow) device in Gastroenterology and Urology.
How is the Modified Dual Lumen Needle supplied and by whom?
The device is supplied by Quinton, Inc., located at 2121 Terry Ave., Seattle, WA 98121, United States, as the manufacturer listed in the FDA 510(k) clearance documentation.
Is the Modified Dual Lumen Needle a single-use or reusable device?
The device description identifies it as a 'Set, Dialysis, Single Needle (Co-Axial Flow)' device, and while the data does not explicitly state single-use or reuse, its classification as a dialysis set implies it is intended for single-use in clinical procedures to prevent cross-contamination, consistent with standard dialysis needle sets.