# MCW: Catheter, Peripheral, Atherectomy

- Device class: 2; regulation: 21 CFR 870.4875; FDA's rule: 510(k) required
- FDA decisions: 146
- 510(k) review time 2021–2025: median 83 days (middle half 46–139)
- Recalls: 21 (4 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: 7
- 2018: 8
- 2019: 3
- 2020: 2
- 2021: 6
- 2022: 6
- 2023: 4
- 2024: 3
- 2025: 3
- 2026: 1

## Most-cited predicates
- K081328: Pathway PV Atherectomy System (2008), cited by 15
- K110389: Stealth 360 Orbital Pad System (2011), cited by 9
- K082186: Modification to Pathway PV Atherectomy System (2008), cited by 9
- K960970: Possis Angiojet Rapid Thrombectomy  Catheter System, F105 Catheter,Model 3030C,LF140 Catheter,Model 3040C,Pump Set 3020P (1996), cited by 7
- K061188: Silverhawk Peripheral Plaque Excision System (2006), cited by 7
- K901206: Rotablator (1990), cited by 6
- K091509: Jetstream G2 NXT System, Model PV20300 (2009), cited by 6
- K093456: Jetstream G3 System (2009), cited by 6
- K970080: Arrow-Trerotola PTD Catheter (1997), cited by 6
- K092332: Jetstream G3 System, Model PV31300 ( Jetstream G3 Catheter and Control Pod)., PVCN100 (PV Console) (2009), cited by 6

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