Perfuze, Ltd.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Perfuze, Ltd.” (first 2022, latest 2026), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 61 days. Since 2017 the median was 61 days, against 140 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2022 | 1 | 267 |
| 2023 | 3 | 61 |
| 2024 | 2 | 122 |
| 2025 | 2 | 42 |
| 2026 | 3 | 119 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Perfuze, Ltd. took a median 61 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 140 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NRY | Catheter, Thrombus Retriever | 6 | 6 |
| QJP | Catheter, Percutaneous, Neurovasculature | 5 | 5 |
Review panels
- Neurology (11)
Most recent Perfuze, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K262399 | Millipede System | NRY | 2026-08-12 | 29 |
| K253901 | Millipede88 Access Catheter | QJP | 2026-07-09 | 216 |
| K253590 | Millipede System | NRY | 2026-03-16 | 119 |
| K252392 | Millipede70 Aspiration Catheter; Perfuze Aspiration Tube Set | NRY | 2025-08-29 | 29 |
| K250012 | Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set | NRY | 2025-02-26 | 55 |
| K240711 | Zipline Access Catheter | QJP | 2024-10-17 | 216 |
| K242504 | Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set | NRY | 2024-09-20 | 29 |
| K233648 | Millipede 088 Access Catheter | QJP | 2023-12-14 | 30 |
| K232524 | Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set | NRY | 2023-10-18 | 61 |
| K231802 | Millipede 088 Access Catheter | QJP | 2023-09-19 | 91 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Perfuze, Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Perfuze, Ltd. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT05714501: Millipede AspiRation for Revascularization in Stroke (MARRS) Study (Completed, started 2023-10-09)
Frequently asked questions
How many FDA 510(k) clearances are listed under Perfuze, Ltd.?
FDA lists 11 510(k) clearances under the applicant name “Perfuze, Ltd.” (first 2022, latest 2026), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Perfuze, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Perfuze, Ltd. is 61 days. Since 2017: 61 days, versus 140 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Perfuze, Ltd.?
The most frequent FDA product codes under this applicant name are NRY (Catheter, Thrombus Retriever, 6); QJP (Catheter, Percutaneous, Neurovasculature, 5).
Next steps
- See all 11 Perfuze, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code NRY, Perfuze, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.