Medical Device Manufacturer · IE , Galway

Perfuze, Ltd.

8 submissions · 8 cleared · Since 2022

8

Total

8

Cleared

0

Denied

Perfuze, Ltd. — FDA 510(k) Submissions

Perfuze, Ltd. has submitted 8 FDA 510(k) premarket notifications since 2022, of which 8 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Catheter, Percutaneous, Neurovasculature, Catheter, Thrombus Retriever . Use the specialty filter in the sidebar to narrow results.

8 devices

1–8 of 8

Millipede70 Aspiration Catheter; Perfuze Aspiration Tube Set

K252392 · NRY Catheter, Thrombus Retriever · Neurology

Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set

K250012 · NRY Catheter, Thrombus Retriever · Neurology

Zipline Access Catheter

K240711 · QJP Catheter, Percutaneous,... · Neurology

Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set

K242504 · NRY Catheter, Thrombus Retriever · Neurology

Millipede 088 Access Catheter

K233648 · QJP Catheter, Percutaneous,... · Neurology

Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set

K232524 · NRY Catheter, Thrombus Retriever · Neurology

Millipede 088 Access Catheter

K231802 · QJP Catheter, Percutaneous,... · Neurology

Millipede 088 Access Catheter

K214048 · QJP Catheter, Percutaneous,... · Neurology

Data Source

FDA 510(k) public files . 174,402 total devices indexed.