# QEZ: Aspiration Thrombectomy Catheter

- Device class: 2; regulation: 21 CFR 870.5150; FDA's rule: 510(k) required
- FDA decisions: 95
- 510(k) review time 2021–2025: median 96 days (middle half 59–130)
- Recalls: 0 (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)
- 2017: 3
- 2018: 1
- 2019: 3
- 2020: 3
- 2021: 3
- 2022: 2
- 2023: 1
- 2024: 1
- 2025: 5
- 2026: 6

## Most-cited predicates
- K063371: Pronto V3 Extraction Catheter, Model 5003 (2006), cited by 8
- K032763: Vascular Solutions Pronto Extraction Catheter (2003), cited by 8
- K061958: Medtronic Export XT Catheter (2006), cited by 7
- K052256: Angiojet Xpeedior 120 Catheter (2005), cited by 6
- K040869: Export Catheter (2004), cited by 6
- K972610: Possis Angiojet Rapid Thombectomy Catheters--F105 Catheter Model 3030C, LF140 Catheter Model 3040C (2000), cited by 6
- K040013: Angiojet Xpeedior 120 Catheter and Angiojet Power Pulse Spray Ancillary Kit (2004), cited by 5
- K051193: Vascular Solutions Pronto Short Extraction Catheter (2005), cited by 4
- K052232: Vascular Solutions Pronto V3 Extraction Catheter (2005), cited by 4
- K083784: Pronto V3 Extraction Center, Model 5003, Pronto LP Extraction Catheter, Model 5010, Skyway RX Support Catheter, (2009), cited by 4

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