12F Tri-Flow Triple Lumen Catheter
by Medical Components, Inc. (dba MedComp)
510(k) K181175
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESK | NumberK181175 | Date5 Jul 2018 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- NIE
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5540
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESK Substantially Equivalent — Kit
Overview
AI-generated summary, 1 Oct 2026
This device is a Triple Lumen Catheter, Non-Implanted (per FDA nomenclature), designed for short-term vascular access. It features three independent lumens to facilitate simultaneous infusion, withdrawal, or dialysis procedures. The tapered tip and polyurethane construction enhance compatibility with venous anatomy while reducing trauma during insertion. Its triple-lumen configuration supports hemodialysis and apheresis applications, ensuring efficient fluid management in clinical settings.
The 12F Tri-Flow Triple Lumen Catheter is supplied as a sterile, single-use device, intended for percutaneous insertion into the internal jugular, subclavian, or femoral veins. Available in 12F size with straight or curved configurations, it requires no additional sterilization beyond manufacturer packaging. Compliance with FDA 510(k) clearance (K181175) and regulatory classification II ensures adherence to medical device standards. Storage follows standard sterile medical device protocols, and its use is restricted to short-term (< 30 days) vascular access procedures.
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Questions
AI-generated answers, 1 Oct 2026
What is the 12F Tri-Flow Triple Lumen Catheter designed for?
This catheter is specifically engineered for short-term vascular access, up to 30 days, to facilitate simultaneous infusion, withdrawal, or dialysis procedures. Its triple-lumen design supports hemodialysis and apheresis, making it ideal for clinical settings requiring efficient fluid management, such as intensive care or dialysis units.
How is the 12F Tri-Flow Triple Lumen Catheter supplied and prepared for use?
The catheter is supplied sterile and pre-packaged by the manufacturer, eliminating the need for additional sterilization. It is intended for single-use only, ensuring patient safety and compliance with medical device standards. The packaging maintains sterility until immediate use.
What vein insertion sites are compatible with this catheter, and why?
The 12F Tri-Flow Triple Lumen Catheter is designed for percutaneous insertion into the internal jugular, subclavian, or femoral veins. Its tapered polyurethane tip reduces trauma during insertion, improving compatibility with venous anatomy and minimizing patient discomfort or complications.
Are there different configurations available for this catheter, and what do they entail?
Yes, this catheter is available in two configurations: straight and curved. The curved tip may offer advantages for specific anatomical access challenges, such as navigating the subclavian vein or femoral approach, while the straight tip provides a more traditional insertion profile for other sites.
How should the 12F Tri-Flow Triple Lumen Catheter be stored, and what are the key considerations?
Storage follows standard sterile medical device protocols to preserve integrity and sterility. The catheter should be stored in its original, unopened packaging in a clean, dry environment, away from direct sunlight or extreme temperatures. Proper storage ensures the device remains ready for immediate use when needed, maintaining its performance and safety.