Approval time for 510(k) pathway devices excluding embolic agents
| Variable | Mean | P value |
| Category | ||
| Aspiration system | 115.0±78.3 | 0.01 |
| Microwire | 73.0±61.2 | |
| Microcatheter | 179.4±141.7 | |
| Intracranial access+balloon guide | 138.4±95.5 | |
| Stent retriever | 131.8±101.4 | |
| Predicate Device | ||
| Yes | 107.5±87.9 | <0.01 |
| No | 176.0±108.9 | |
| Country | ||
| USA | 118.7±90.4 | 0.01 |
| Other country | 173.8±128.4 | |
| Company status | ||
| Public | 126.1±96.6 | 0.84 |
| Private | 132.1±106.6 | |
| M&A | 118.8±93.2 | |
| Number of devices | ||
| Companies ≥5 | 113.6±91.3 | <0.01 |
| Companies <5 | 174.7±109.1 |
M&A, mergers and acquisitions.