FDA product code · Cardiovascular · Class 2
PZX: Left Atrial Appendage Clip, Implantable
PZX is FDA's product code for "Left Atrial Appendage Clip, Implantable": a Class 2 device classified under 21 CFR 878.4300, reviewed by the Cardiovascular panel.
510(k) review time for PZX
Across 10 510(k) clearances under PZX decided from 2018-01-01 to 2026-10-06, the median was 58 days from FDA receipt to decision. Half took between 29 and 205 days, and 80% were decided within 222 days. These are past clearances, not a forecast for a new submission.
| Fastest | 24 |
|---|---|
| 25th percentile | 29 |
| Median | 58 |
| 75th percentile | 205 |
| 80th percentile | 222 |
| 90th percentile | 254 |
| Slowest | 268 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
FDA-recognized standards that cite PZX
No FDA recognized consensus standard cites PZX by product code. Horizontal standards such as biocompatibility, sterilization and software standards can still apply.
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.