HARMAC MEDICAL PRODUCTS, INC.

Harmac Medical Products, Inc. manufactures cardiovascular catheters and related accessories, including balloon wedge pressure catheters, bipolar and quadripolar temporary pacing catheters with stylet, thermodilution catheters, balloon angiographic catheters, extension infusion sets, and Huber needle safety devices. These products are designed for diagnostic and therapeutic use in cardiovascular procedures, such as pressure monitoring, cardiac pacing, and fluid infusion.

Harmac Medical Products, Inc. is based in the United States, as stated in the company’s country field within the provided data. This indicates the company’s primary operational and legal jurisdiction is within the U.S., though no specific city or state is disclosed in the source material.

Harmac Medical Products, Inc.'s devices are listed in the FDA 510(k) registry, as explicitly noted in the LISTED IN field of the device data. This registry contains premarket notifications for medical devices that have demonstrated substantial equivalence to legally marketed predicate devices, allowing them to be legally marketed in the U.S.

Harmac Medical Products, Inc.'s devices are classified as Class II medical devices, as specified in the DEVICE CLASSES field. Class II devices are subject to special controls to ensure safety and effectiveness, such as performance standards, post-market surveillance, and specific labeling requirements, but do not require premarket approval unless they are high-risk or novel.