# QJP: Catheter, Percutaneous, Neurovasculature

- Device class: 2; regulation: 21 CFR 870.1250; FDA's rule: 510(k) required
- FDA decisions: 103
- 510(k) review time 2021–2025: median 165 days (middle half 87–247)
- Recalls: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2020: 9
- 2021: 12
- 2022: 14
- 2023: 14
- 2024: 18
- 2025: 14
- 2026: 22

## Most-cited predicates
- K212838: Benchmark Intracranial Access System (2022), cited by 4
- K212224: TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform (2021), cited by 3
- K203764: TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform (2021), cited by 3
- K202752: AXS Vecta 46 Intermediate Catheter (2021), cited by 2
- K211594: Trevo Trak 21 Microcatheter (2021), cited by 2
- K231393: Radical the Dude 7F Guide Catheter (2023), cited by 2
- K240971: 87 NeuGlide Catheter (2024), cited by 2
- K200121: Route 92 Medical 088 Access System, 110 cm (2020), cited by 2
- K201518: Route 92 Medical 088 Access System (2020), cited by 2
- K242051: VersaD Delivery Catheter (2025), cited by 1

Source page: https://510kreport.com/product-code/QJP
Data by year (CSV): https://510kreport.com/product-code/QJP.csv