Combowire Pressure and Flow Guide Wire, Combotip Pressure and Flow Guide Wire
by Volcano Therapeutics, Inc. EUDAMED510(k)
Active
510(k) K042996
Overview
This device is a pressure and flow guide wire, designed for use in coronary and peripheral vascular interventions. It combines diagnostic and therapeutic capabilities, allowing simultaneous measurement of pressure and flow while facilitating catheter navigation within blood vessels.
The Combowire and Combotip guide wires are supplied as single-use devices, intended for use in cardiac catheterization laboratories. They are intended for use with compatible pressure and flow measurement systems and are regulated under the FDA 510(k) pathway with a Special clearance type, classified under product code DQX. Sterility and MRI safety are not specified in the provided data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK042996 | Date24 Nov 2004 | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DQX
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1330
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Volcano Therapeutics, Inc.
Questions
What types of procedures can the Combowire and Combotip guide wires be used for, and why are they advantageous in those settings?
The Combowire and Combotip guide wires are designed for coronary and peripheral vascular interventions, combining diagnostic and therapeutic functions. They allow simultaneous measurement of pressure and flow while guiding catheters through blood vessels, which is particularly useful in complex cases where real-time hemodynamic data is critical. This dual capability helps clinicians assess vessel physiology and navigate catheters more effectively during procedures like angioplasty or stent placement.
Are these guide wires intended for reuse, or are they single-use devices? How does this affect their use in a cardiac catheterization lab?
The Combowire and Combotip guide wires are explicitly supplied as single-use devices, meaning each wire is intended for one procedure only. This design choice helps maintain sterility and reduces the risk of cross-contamination between patients, which is especially important in sterile environments like cardiac catheterization labs. Clinicians should follow standard single-use protocols, including proper disposal after use.
What regulatory pathway was followed for clearance of these guide wires, and what does that mean for clinicians using them?
The Combowire and Combotip guide wires were cleared through the FDA’s 510(k) pathway with a Special clearance type, classified under product code DQX and reviewed by the Cardiovascular (CV) Advisory Committee. This means the device was determined to be substantially equivalent to a legally marketed predicate, ensuring it meets established safety and performance standards for coronary and peripheral vascular guide wires. Clinicians can rely on this clearance as evidence of regulatory scrutiny for use in diagnostic and therapeutic coronary/peripheral interventions.
How are these guide wires supplied, and what should clinicians consider when handling them before use?
The Combowire and Combotip guide wires are supplied as single-use devices, though specific packaging details (e.g., sterile packaging, packaging type) are not provided in the data. Clinicians should assume standard sterile handling protocols for single-use medical devices, including checking for any visible damage to the packaging before opening. Since they are intended for use with compatible pressure and flow measurement systems, compatibility with the lab’s existing equipment should also be verified prior to use.