1 device · 1 company · 2026
Product code OBJ: Catheter, Ultrasound, Intravascular
1 device under product code OBJ, 2026, from 1 company. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (1 of 1 here), the regulation, and MAUDE report counts by product code.
Catheter, Ultrasound, Intravascular. 21 CFR 870.1200, Class II. For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology. MAUDE held 8,056 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| Novasight Hybrid SystemK252945 · 510(k) | Conavi Medical, Inc. | Cardiovascular | database entry |
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