FDA product code SJJ: Cardiac Device Identifier
SJJ is the FDA product code for cardiac device identifier. It is a Class II device, regulated under 21 CFR 870.3645 and reviewed by the Cardiovascular panel. Devices under SJJ reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
A cardiac device identifier is a noninvasive device that is intended to provide information about implanted cardiac devices. The device detects and matches telemetry based on manufacturer-specific wireless communication signals, including radiofrequency or inductive signals, to identify an implanted cardiac device, including manufacturer, model, or type. The device is not intended to deliver therapeutic stimulation to, modify the programming of, or manipulate the stored data of the implanted device.
Classification
| Field | Value |
|---|---|
| Device name | Cardiac Device Identifier |
| Device class | Class II |
| Regulation | 21 CFR 870.3645 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
Recalls for SJJ devices
FDA recall records list no recalls for product code SJJ.
Frequently asked questions
What is FDA product code SJJ?
SJJ is the FDA product code for cardiac device identifier. It is a Class II device, regulated under 21 CFR 870.3645 and reviewed by the Cardiovascular panel.
What device class is SJJ?
Class II, regulation 21 CFR 870.3645. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code SJJ
- Run a recall and safety report across every SJJ manufacturer
- Watch product code SJJ for new clearances and recalls
Compiled by Caduvo from public U.S. FDA records. Applicant names are shown as FDA records them. Review days run from FDA receipt to decision. Not reviewed or endorsed by FDA. Not regulatory advice. Report an error. Data and corrections policy.
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