FDA product code QAB: Pacing System Analyzer
QAB is the FDA product code for pacing system analyzer. It is a Class II device, regulated under 21 CFR 870.3605 and reviewed by the Cardiovascular panel. Devices under QAB reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
The device is intended to supply an accurately calibrated, variable pacing pulse for measuring the patients pacing threshold and intracardiac R-wave potential. A pacing system analyzer (PSA) may be a single, dual, or triple chamber system and can simultaneously deliver pacing therapy while testing one or more implanted pacing leads.
Classification
| Field | Value |
|---|---|
| Device name | Pacing System Analyzer |
| Device class | Class II |
| Regulation | 21 CFR 870.3605 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
Recalls for QAB devices
openFDA lists no recalls for product code QAB.
Frequently asked questions
What is FDA product code QAB?
QAB is the FDA product code for pacing system analyzer. It is a Class II device, regulated under 21 CFR 870.3605 and reviewed by the Cardiovascular panel.
What device class is QAB?
Class II, regulation 21 CFR 870.3605. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QAB
- Run a recall and safety report across every QAB manufacturer
- Watch product code QAB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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