Merit Medical Systems, Inc. · Class II · Cleared Jan 15, 2025
| K-number | K242873 |
| Device name | Ventrax Delivery System |
| Applicant | Merit Medical Systems, Inc. |
| Product code | DQY |
| Device class | Class II |
| Decision date | Jan 15, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 870.1250 |
The Ventrax Delivery System is a percutaneous catheter delivery sheath designed to provide a conduit for introducing diagnostic and therapeutic catheters into specific heart chambers and coronary vessels. The system consists of an 8.5F guiding sheath introducer, a pigtail dilator, a straight dilator, and a J-tipped Amplatz guidewire that work together to deliver and position catheters at target locations within the heart.
The subject device shares the same basic design, fundamental operation, sterilization method, and intended use as its predicate. Minor technological differences include slight packaging modifications, use of different (but biocompatible) material types meeting ISO 10993-1, and similar labeling. These differences do not raise new safety or efficacy concerns.
ISO 13485, ISO 14971, ISO 11070, ISO 80369-7, ISO 80369-20, IEC 62366-1, ISO 10993 series (parts 1, 3, 4, 5, 7, 10, 11, 12), AAMI ST72, ISO 11135, AAMI TIR 28, ASTM D999-08, ASTM D5265-23, ASTM F2096-11, ASTM D4169, ISO 2233, AAMI ISO 11607, ASTM F1929, ASTM F88/F88M, and ASTM F1980.
The subject device is substantially equivalent because it has identical indications for use, same clinical application, identical basic design and technology/principle of operation, and same sterilization method as the predicate device (K231246). Comprehensive biocompatibility testing confirmed the device meets requirements for externally communicating devices with limited circulating blood contact, and extensive design verification and packaging testing demonstrated the device meets acceptance criteria for safety and efficacy equivalent to the predicate.
View the full FDA submission: accessdata.fda.gov