Flowire and Flomap
by Cardio Metrics, Inc. 510(k)
Active
510(k) K905411
Overview
The Flowire and Flomap are blood flowmeters designed for cardiovascular applications. These devices measure and monitor blood flow within the circulatory system, providing critical data for diagnostic and research purposes in clinical settings. They are classified as Class II medical devices under FDA regulations, specifically under the product code DPW for blood flowmeters.
These devices are intended for use in radiology and cardiovascular diagnostic procedures. Supplied as reusable medical instruments, they are regulated under FDA 510(k) clearance (K905411, K912776, K932536) and fall under the regulation number 870.2100. They are not single-use and require proper maintenance and calibration to ensure accurate measurements. No specific MRI safety information is provided in the data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK905411 | Date29 Mar 1991 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 5 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DPW
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2100
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Cardio Metrics, Inc.
Questions
What are the Flowire and Flomap devices used for?
The Flowire and Flomap are designed specifically for measuring and monitoring blood flow within the circulatory system during cardiovascular and radiology diagnostic procedures. They provide critical data to support clinical assessments and research, ensuring accurate hemodynamic evaluations in controlled settings.
Are the Flowire and Flomap devices single-use or reusable?
The Flowire and Flomap are reusable medical instruments. Like all reusable devices, they require proper maintenance, cleaning, and regular calibration to ensure consistent accuracy and reliability over repeated use. Failure to follow maintenance protocols could compromise measurement precision.
What regulatory pathway do these devices follow?
Both devices are classified as Class II under FDA regulations (product code DPW) and have obtained FDA 510(k) clearance (K905411, K912776, K932536). They fall under regulation number 870.2100 and were reviewed by the FDA’s Cardiovascular (CV) Advisory Committee. This pathway confirms their substantial equivalence to predicate devices already on the market.
Do the Flowire and Flomap devices require special storage conditions?
While the provided data does not specify exact storage requirements, reusable medical devices like these generally need protection from physical damage, contamination, and environmental extremes (e.g., extreme temperatures or humidity). Manufacturers typically recommend storing them in a clean, dry environment and following the manufacturer’s instructions for long-term preservation to maintain functionality.
Are there any known limitations or special considerations for use?
The Flowire and Flomap are intended for clinical and research use in radiology and cardiovascular diagnostics, but their accuracy depends on proper setup, calibration, and adherence to manufacturer guidelines. No MRI safety information is provided, so users should verify compatibility with their specific MRI systems if used in such environments. Additionally, their performance may vary based on the specific application and patient physiology.