Combomap Pressure and Flow System
by Volcano Therapeutics, Inc. 510(k)
Active
510(k) K041134
Overview
The Combomap Pressure and Flow System is an intravascular catheter designed for simultaneous measurement of pressure and blood flow within coronary arteries. It integrates ultrasound imaging with real-time hemodynamic data to assess coronary physiology, supporting diagnostic and interventional procedures in cardiovascular care. The device combines intravascular ultrasound (IVUS) with Doppler flow measurement to provide comprehensive vascular assessment.
This system is intended for use in catheterization laboratories by trained medical professionals. It is supplied as a reusable device, requiring appropriate cleaning, sterilization, and maintenance per manufacturer guidelines. The system is classified as Class II under FDA regulations (870.1200) and holds a Special 510(k) clearance (K041134) for cardiovascular applications. Multiple model variants are referenced in regulatory filings, though specific sizes or configurations are not detailed in the provided data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK041134 | Date2 Jun 2004 | 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- Withdrawn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
- OBJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1200
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Volcano Therapeutics, Inc.
Questions
What is the Combomap Pressure and Flow System used for?
The Combomap Pressure and Flow System is designed for simultaneous measurement of pressure and blood flow within coronary arteries. It integrates intravascular ultrasound (IVUS) with Doppler flow measurement to provide comprehensive vascular assessment, supporting diagnostic and interventional procedures in cardiovascular care. This helps clinicians evaluate coronary physiology during catheterization lab procedures.
Is the Combomap Pressure and Flow System reusable or single-use?
The Combomap Pressure and Flow System is a reusable device. It requires proper cleaning, sterilization, and maintenance as outlined by the manufacturer’s guidelines to ensure safe and effective use across multiple procedures.
What regulatory approval does the Combomap Pressure and Flow System hold?
The device holds a Special 510(k) clearance (K041134) from the FDA, classified under Class II (870.1200) for cardiovascular applications. This clearance indicates it is deemed substantially equivalent to a predicate device already on the market, ensuring compliance with regulatory standards for use in catheterization labs.
Are there multiple model variants of the Combomap Pressure and Flow System?
Multiple model variants of the Combomap Pressure and Flow System are referenced in regulatory filings, though specific sizes or configurations are not detailed in the provided data. These variants likely cater to different clinical needs or procedural requirements within coronary interventions.
How does the Combomap Pressure and Flow System differ from traditional coronary assessment tools?
Unlike traditional tools that measure either pressure or flow separately, the Combomap Pressure and Flow System combines both IVUS imaging and Doppler flow measurement in real time. This dual functionality provides a more holistic assessment of coronary artery physiology, enabling clinicians to evaluate both structural and functional aspects simultaneously during procedures.