Hjarta Care, LLC is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Hjarta Care, LLC - FDA 510(k) Cleared Devices
1
Total
0
Cleared
1
Denied
Hjarta Care, LLC develops cardiovascular surgical devices, with a manufacturing facility in Waukesha, Wisconsin. The company specializes in innovative tools for complex vascular procedures, particularly endograft explantation.
Hjarta Care has submitted 1 FDA 510(k) application and received 0 clearances in the cardiovascular category. The company received FDA De Novo authorization for its flagship XplantR Explant Tool, a purpose-built device designed to simplify open aortic endograft removal. This represents a significant advancement in vascular surgery instrumentation.
The company is currently inactive and should be treated as a historical regulatory record. Explore the device names, product codes, and clearance dates in the full 510(k) database for additional details.
FDA 510(k) Regulatory Record - Hjarta Care, LLC
1 devices