8 French Dilator 15cm, W/Luer Lock
by Quinton, Inc. 510(k)
Active
510(k) K833965
Overview
This device is a dilator, vessel, for percutaneous catheterization (product code DRE), designed to gradually enlarge a vessel’s lumen to facilitate the insertion of catheters or guidewires. It operates by mechanical dilation, ensuring controlled expansion of vascular access sites during interventional procedures.
The 8 French Dilator 15cm with Luer Lock is supplied as a single-use, non-sterile device intended for sterile preparation prior to use. It is classified as Class II under FDA regulations (regulation number 870.1310) and holds a FDA 510(k) clearance (K833965) for substantial equivalence. The device is compatible with standard vascular access procedures and must be handled according to aseptic techniques.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK833965 | Date16 Dec 1983 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DRE
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1310
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Quinton, Inc.
Questions
What is the primary purpose of the 8 French Dilator 15cm with Luer Lock, and how does it function during procedures?
The 8 French Dilator 15cm with Luer Lock is designed to gradually enlarge a vessel’s lumen through mechanical dilation, making it easier to insert catheters or guidewires during percutaneous catheterization procedures. It ensures controlled expansion of vascular access sites, which is critical for minimizing trauma and improving procedural success.
Is this device intended for single-use or can it be reused? What preparation is required before use?
This device is explicitly labeled as single-use only and is supplied in a non-sterile state. It must be sterilized prior to use following aseptic techniques to ensure patient safety during vascular access procedures. Reuse is not recommended or supported by the manufacturer.
What sizes or models are available for this dilator, and how does the 15cm length factor into its use?
This specific product is the 8 French Dilator 15cm with Luer Lock, meaning it has a French size of 8 (a measurement of diameter) and a length of 15 centimeters. The 15cm length provides sufficient reach for deeper vascular access sites, while the Luer Lock ensures secure attachment to compatible catheters or guidewires during dilation.
How should this device be stored, and are there any special handling instructions?
While the device is non-sterile as supplied, it must be stored in a clean, dry environment away from direct sunlight or extreme temperatures to preserve its integrity. Since it is single-use, it should not be reused after sterilization. Always follow manufacturer guidelines for terminal sterilization (e.g., ethylene oxide or autoclave) if preparing for use, and ensure proper packaging to maintain sterility until deployment.
What regulatory pathway was followed for this device, and which advisory committee was involved?
This device received FDA 510(k) clearance (K833965) under the Traditional 510(k) Review pathway, demonstrating substantial equivalence to a predicate device. The Cardiovascular (CV) Advisory Committee was involved in the review process, as indicated by the product’s classification under FDA regulation 870.1310 and its product code DRE (Dilator, Vessel, for Percutaneous Catheterization).