FDA product code · Cardiovascular · Class 2
PDU: Catheter For Crossing Total Occlusions
PDU is FDA's product code for "Catheter For Crossing Total Occlusions": a Class 2 device classified under 21 CFR 870.1250, reviewed by the Cardiovascular panel.
510(k) review time for PDU
Across 18 510(k) clearances under PDU decided from 2018-01-01 to 2026-10-06, the median was 134 days from FDA receipt to decision. Half took between 63 and 180 days, and 80% were decided within 208 days. These are past clearances, not a forecast for a new submission.
| Fastest | 29 |
|---|---|
| 25th percentile | 63 |
| Median | 134 |
| 75th percentile | 180 |
| 80th percentile | 208 |
| 90th percentile | 266 |
| Slowest | 272 |
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.
PDU in the public FDA record
| 510(k) clearances, all years | 58 |
|---|
Counts of records, not of devices or events. Adverse event reports for PDU are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite PDU
No FDA recognized consensus standard cites PDU 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.