Frontrunner CTO Catheter and Accessories
by Lumend, Inc.
510(k) K033535
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK033535 | Date7 Jan 2004 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Lumend Frontrunner Cto Catheter and Accessories
- 510(k) Number
- FDA Product Code
- PDU
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1250
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Frontrunner CTO Catheter and Accessories is a catheter for crossing total occlusions, designed to assist in the intraluminal placement of conventional guide wires through stenotic lesions—including chronic total occlusions—in both peripheral and coronary blood vessels. This device aids in preparing the vascular pathway for subsequent percutaneous interventions by navigating occluded segments.
The system is supplied as a sterile, single-use device and is intended for use in interventional cardiology and vascular procedures. It is classified as a Class II medical device under FDA regulations (870.1250) and has received FDA 510(k) clearance for its intended purpose. Multiple catheter sizes and configurations are available, as referenced by the listed FEI numbers, to accommodate varying clinical scenarios.
Other devices from Lumend, Inc.
Questions
AI-generated answers, 20 Sep 2026
What types of vascular blockages is the Frontrunner CTO Catheter designed to help navigate, and how does it assist in subsequent procedures?
The Frontrunner CTO Catheter is specifically designed to cross chronic total occlusions (CTOs), which are severe blockages in blood vessels that have been completely closed off for an extended period. It aids in intraluminal placement of conventional guide wires through stenotic lesions—both in peripheral and coronary arteries—to create a pathway for further interventions like angioplasty or stenting. By navigating the occluded segment, it prepares the vessel for additional percutaneous procedures.
Is the Frontrunner CTO Catheter system meant for repeated use, or is it intended as a single-use device?
The Frontrunner CTO Catheter and its accessories are supplied as a sterile, single-use device. This ensures patient safety and maintains sterility standards for interventional procedures, preventing cross-contamination between patients.
What range of catheter sizes and configurations are available for clinical use, and how do they differ?
The system includes multiple catheter sizes and configurations, each identified by unique FEI numbers (e.g., 1721676, 3003637635, etc.). These variations accommodate different clinical scenarios, such as varying vessel diameters, occlusion lengths, or anatomical locations (e.g., coronary vs. peripheral vessels). The exact specifications for each size are detailed in the product documentation, allowing clinicians to select the appropriate catheter for their procedure.
How is the Frontrunner CTO Catheter system regulated, and what does the FDA clearance cover?
The Frontrunner CTO Catheter and Accessories received FDA 510(k) clearance under the Special 510(k) Review Program, with a decision date of January 7, 2004. The clearance is based on a substantially equivalent determination to a predicate device, and it applies to the catheter’s intended use in crossing chronic total occlusions in both coronary and peripheral vessels to facilitate subsequent interventional procedures. The regulatory route confirms compliance with FDA standards for Class II devices (product code: PDU).