SDJ — Adjunctive Cardiac Amyloidosis Status Indicator Class II
FDA product code SDJ covers "Adjunctive Cardiac Amyloidosis Status Indicator", a Class II medical device regulated under 21 CFR 870.2200. Submissions are reviewed by the Cardiovascular panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- SDJ
- Device Class
- Class II
- Regulation Number
- 870.2200
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
The adjunctive cardiac amyloidosis status indicator is a prescription device based on sensor technology or image data to provide information to an interpreting clinician in detecting cardiac amyloidosis. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.