# Perfuze, Ltd.

- Location (FDA's records): Galway, IE
- FDA decisions: 11 (2022–2026): 11 510(k) clearances
- Product codes: NRY (6), QJP (5)
- 510(k) review time since 2016: median 61 days, against 147 for FDA's reviews in the same codes and years (8 of 11 faster)
- Predicates its devices cite: 12 (8 its own); citations of its devices by later devices: 8 (8 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Route 92 Medical, Inc.: 2 (https://510kreport.com/company/route-92-medical)
- MicroVention, Inc.: 1 (https://510kreport.com/company/microvention)
- Imperative Care, Inc.: 1 (https://510kreport.com/company/imperative-care)

## Its most-cited devices
- K242504: Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set (2024), cited by 2
- K233648: Millipede 088 Access Catheter (2023), cited by 1
- K232524: Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set (2023), cited by 1
- K214048: Millipede 088 Access Catheter (2022), cited by 1
- K253590: Millipede System (2026), cited by 1
- K231802: Millipede 088 Access Catheter (2023), cited by 1

## Recent decisions
- K262399: Millipede System (Aug 12, 2026)
- K253901: Millipede88 Access Catheter (Jul 9, 2026)
- K253590: Millipede System (Mar 16, 2026)
- K252392: Millipede70 Aspiration Catheter; Perfuze Aspiration Tube Set (Aug 29, 2025)
- K250012: Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set (Feb 26, 2025)
- K240711: Zipline Access Catheter (Oct 17, 2024)
- K242504: Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set (Sep 20, 2024)
- K233648: Millipede 088 Access Catheter (Dec 14, 2023)

Source page: https://510kreport.com/company/perfuze