Plume Y Set
by Hospal Medical Corp. 510(k)
Active
510(k) K854951
Overview
The Plume Y Set is a Needle, Fistula device designed for vascular access procedures in Gastroenterology and Urology. It facilitates the connection of infusion or drainage lines to a fistula or vascular access port, enabling secure and controlled fluid administration or withdrawal. Constructed for use in clinical settings requiring precise and reliable vascular access, it supports procedures such as hemodialysis, chemotherapy, or other therapeutic interventions.
This device is supplied as a single-use medical product and is regulated under FDA 510(k) clearance (K854951) with a Traditional review pathway. It falls under Class II classification and is intended for sterile use in controlled clinical environments. The Plume Y Set is distributed by Hospal Medical Corp. and adheres to regulatory standards outlined in 21 CFR 876.5540, ensuring compliance with safety and performance requirements for vascular access devices.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK854951 | Date8 Jan 1986 | 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- Withdrawn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
- FIE
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5540
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Hospal Medical Corp.
Questions
What is the Plume Y Set used for in clinical settings?
The Plume Y Set is designed specifically for vascular access procedures in Gastroenterology and Urology. It securely connects infusion or drainage lines to a fistula or vascular access port, enabling controlled fluid administration or withdrawal. This is particularly useful for procedures like hemodialysis, chemotherapy, or other therapeutic interventions requiring reliable vascular access.
Is the Plume Y Set intended for single-use or reusable applications?
The Plume Y Set is supplied as a single-use medical product. This ensures patient safety by preventing cross-contamination and maintaining sterility between uses, which is critical for procedures involving vascular access.
What regulatory pathway does the Plume Y Set follow, and what class does it belong to?
The Plume Y Set is regulated under the FDA 510(k) clearance pathway with a Traditional review, and it is classified as a Class II medical device. This classification indicates that it poses moderate risk and requires compliance with specific regulatory standards, including those outlined in 21 CFR 876.5540.
Does the Plume Y Set come sterile, and how should it be stored?
Yes, the Plume Y Set is intended for sterile use. It should be stored in a clean, dry environment, protected from contamination and extreme temperatures. Proper storage ensures the device remains uncontaminated and ready for use in controlled clinical settings.
What sizes or models of the Plume Y Set are available?
The Plume Y Set is available in multiple configurations, as indicated by the FEI product code and various registration numbers (e.g., 8041145, 9615908, etc.). These variations likely correspond to different sizes or adaptations for specific clinical applications, ensuring compatibility with diverse vascular access needs in Gastroenterology and Urology.