Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 ); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for GE Systems) (10043342)
Surgical Instrument Service and Savings Inc.The Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter is a reprocessed ultrasound catheter designed for imaging inside the heart and great vessels of adult patients. It assists clinicians by providing intracardiac and intraluminal visualization using the ultrasound modality. The catheter is intended for imaging guidance during cardiac interventional procedures, improving visualization of cardiac anatomy and device placement without treatment delivery.
Intended Use
The Medline ReNewal Reprocessed Siemens ACUSON AcuNav Ultrasound Catheter 10F is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.
Technology
The device is a reprocessed intravascular ultrasound catheter with the same technological characteristics as the predicate. It is maneuverable and connects to compatible ACUSON consoles via a module interface for intracardiac scanning and visualization. Reprocessing limits usage to one cycle, with tracked device lifecycle.
Performance
Functional equivalence to the predicate device was demonstrated by tests including simulated use, visual inspection, mechanical and ultrasound transducer testing, dimensional analysis, electrical safety, cleaning validation, biocompatibility, sterilization validation, and packaging/shelf life validation.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/30/2024
5 months - 2
FDA Approval
3/10/2025
Other devices from Surgical Instrument Service and Savings Inc.
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.