Peritoneal Lavage Cath PLC-8, Set PLS-8, Kit PLK-8
by Medical Components, Inc. 510(k)
Active
510(k) K860155
Overview
The Peritoneal Lavage Cath PLC-8, Set PLS-8, and Kit PLK-8 are single-use peritoneal dialysis catheters designed for peritoneal lavage procedures. These devices facilitate the infusion and drainage of fluids within the peritoneal cavity, aiding in diagnostic or therapeutic peritoneal dialysis processes.
The kit includes a catheter (PLC-8), a set (PLS-8), and a complete assembly (PLK-8), all intended for single-use applications. Regulated under FDA product code FKO and 21 CFR 876.5630, these devices are classified as Class II medical devices. They are supplied sterile and intended for use in clinical settings such as gastroenterology and urology procedures, adhering to standard sterile field protocols.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESD | NumberK860155 | Date14 Feb 1986 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FKO
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5630
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESD Substantially Equivalent — Deferred
Other devices from Medical Components, Inc.
Questions
Are these peritoneal dialysis catheters reusable or intended for single-use only, and how does that affect their storage requirements?
These devices are explicitly designed for single-use only, as stated in the description and confirmed by the product name ('Single Use' in the OpenFDA data). Because they are sterile upon packaging, they must be stored in their original, unopened packaging to maintain sterility until use. Avoid exposure to moisture, extreme temperatures, or direct sunlight, and ensure the packaging remains intact to prevent contamination.
What clinical specialties are these devices most commonly used in, and why?
These catheters are primarily used in gastroenterology and urology procedures, as indicated by the advisory committee (GU) and medical specialty descriptions in the data. They are specifically designed for peritoneal lavage, which involves fluid infusion and drainage within the peritoneal cavity—a procedure relevant to both specialties for diagnostic or therapeutic peritoneal dialysis.
How do I know which model (PLC-8, PLS-8, or PLK-8) is right for my procedure, and are they interchangeable?
The PLC-8 is the standalone catheter, the PLS-8 is the set (likely including accessories like connectors or tubing), and the PLK-8 is the complete kit (assembled for immediate use). While they share the same core function, they are not interchangeable—each is part of a progressive assembly. Choose based on whether you need just the catheter, a pre-assembled set, or a full kit ready for use, ensuring compatibility with your facility’s workflow.
What regulatory pathway was followed for FDA clearance, and does this affect how I should handle or document these devices?
These devices were cleared via a traditional 510(k) pathway (as noted by the `FDA_510K` and `clearance_type: Traditional` data), meaning their safety and effectiveness were compared to a legally marketed predicate device. While this doesn’t change clinical handling, it does mean the device is classified under 21 CFR 876.5630 and product code FKO, which may be relevant for inventory tracking, procurement, or compliance documentation in your facility.