Medtronic, Inc. · Class II · Cleared Jan 20, 2026
| K-number | K253998 |
| Device name | Clearview Intracoronary Shunts |
| Applicant | Medtronic, Inc. |
| Product code | DWF |
| Device class | Class II |
| Decision date | Jan 20, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 870.4210 |
The Clearview Intracoronary Shunts are disposable tubes with teardrop-shaped radiopaque tips used to temporarily shunt blood away from a coronary artery during beating heart bypass surgery while maintaining blood flow to the heart muscle. The device consists of a flexible tube with tip diameters ranging from 1.00 mm to 3.00 mm, a 14 mm distance between ends, and a permanently attached radiopaque tether tag.
The device shares the same intended use, operating principle, design features, sterilization method (ethylene oxide), shelf-life, materials of construction, and packaging configuration as the predicate device. The modifications made were limited to updated indications for use and labeling changes, with equivalent packaging materials and configuration.
Not stated in this summary.
The Clearview Intracoronary Shunts are substantially equivalent to the predicate device (Clearview Intracoronary Shunts K120612) because they maintain identical design, materials, operating principles, sterilization methods, and technological characteristics. The only modifications are labeling updates and indications for use changes, which do not alter the fundamental device function or raise new safety or effectiveness questions.
View the full FDA submission: accessdata.fda.gov