FDA.reportPublic FDA data

PERFUZE

Matched from indexed company URL: PERFUZE LIMITED

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30157017153015701715PERFUZE1N2026-01-01Unit 6 Galway Business Park Dangan Galway IE H91 W7CP

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3129841142311874K253590Millipede SystemNRY2026-03-16
3129841787967179K252392Millipede70 Aspiration Catheter; Perfuze Aspiration Tube SetNRY2025-08-29
3129841206780313K250012Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube SetNRY2025-02-26
3129841011836071K242504Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube SetNRY2024-09-20
3129841019606941K240711Zipline Access CatheterQJP2024-10-17
3129841009786141K233648Millipede 088 Access CatheterQJP2023-12-14
3129841950315077K232524Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube SetNRY2023-10-18
3129841844387604K231802Millipede 088 Access CatheterQJP2023-09-19
3129841221330602K214048Millipede 088 Access CatheterQJP2022-09-20

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NRY52026-03-16
QJP42024-10-17

PMN#

GUDID#

Millipede 088 Access Catheter - The Millipede 088 Access Catheter consists of the catheter, a rotating hemostasis valve (RHV) and a valve crossing tool. The catheter, RHV and valve crossing tool are provided sterile. They are sterilized by ethylene oxide (EO).The Millipede 088 Access Catheter is a single lumen, reinforced, variable stiffness catheter. The distal segment has a hydrophilic coating for navigation through the vasculature. The catheter has a radiopaque marker located at its distal end for visualization under fluoroscopy. The valve crossing tool is used to open the valve of the access sheath and to facilitate insertion of the Millipede 088 Access Catheter through the access sheath without damage. The RHV is assembled onto the hub of the Millipede 088 Access Catheter and is used to maintain hemostasis during infusion of saline and contrast agent and insertion of other devices through the Millipede 088 Access Catheter.

PERFUZE LIMITED

2026-03-24

Millipede70 Aspiration Catheter - The Millipede70 Aspiration Catheter is a sterile single-use device. It consists of the catheter and a rotating hemostasis valve (RHV). The catheter is a single lumen, reinforced, variable stiffness catheter. The distal segment has a hydrophilic coating for navigation through the vasculature. The catheter has a radiopaque marker located at its distal end for visualization under fluoroscopy. The RHV is assembled onto the hub of the catheter and is used to maintain hemostasis during infusion of saline and contrast agent and insertion of devices into the Millipede70 Aspiration Catheter. For the aspiration source, the Millipede70 Aspiration Catheter is used in conjunction with a compatible aspiration pump with prespecified performance parameters. The aspiration pump is connected using the Perfuze Aspiration Tube Set along with a legally marketed canister and accessories kit.

PERFUZE LIMITED

2025-09-08

Millipede 070 Aspiration Catheter - The Millipede 070 Aspiration Catheter is a sterile single-use device. It consists of the catheter and a RHV. The catheter is a single lumen, reinforced, variable stiffness catheter. The distal segment has a hydrophilic coating for navigation through the vasculature. The catheter has a radiopaque marker located at its distal end for visualization under fluoroscopy. The RHV is assembled onto the hub of the catheter and is used to maintain hemostasis during infusion of saline and contrast agent and insertion of devices into the Millipede 070 Aspiration Catheter.For the aspiration source, the Millipede 070 Aspiration Catheter is used in conjunction with a compatible aspiration pump with prespecified performance parameters that is connected using the Perfuze Aspiration Tube Set along with a legally marketed canister and accessories kit.

PERFUZE LIMITED

2025-06-24

Zipline 070 Access Catheter - The Zipline 070 Access Catheter is a single-use device designed to deliver large-bore catheters to the neurovasculature using standard endovascular techniques. It is supplied sterile and nonpyrogenic. Zipline 070 is designed for use with outer catheters with 0.070” or larger internal diameter. During use, the Zipline 070 Access Catheter is advanced over a guidewire to the desired location in the neurovasculature. An outer catheter is then advanced over the Zipline 070 Access Catheter to the desired location. The Zipline 070 Access Catheter is a single lumen, variable stiffness catheter. It has a tapered flexible tip and a radiopaque marker at its distal end. Proximal to the tapered section is a “bulb” and a radiopaque coil to facilitate bulb visualization under fluoroscopy. The outer diameter of the bulb is designed to closely match the inner diameter of outer catheters, thereby minimizing the gap between the two catheters during navigation.The Zipline 070 Access Catheter has a hydrophilic coating on the outer surface of the distal end to enhance tracking through the vasculature. A luer fitting located on the catheter hub is used for attachment of ancillary devices. A continuous internal lumen spanning from the distal tip to the proximal hub accommodates guidewires up to 0.018” in diameter.

PERFUZE LIMITED

2024-11-30

Zipline 088 Access Catheter - The Zipline 088 Access Catheter is a single-use device designed to deliver large-bore catheters to the neurovasculature using standard endovascular techniques. It is supplied sterile and nonpyrogenic. Zipline 088 is designed for use with outer catheters with 0.088” or larger internal diameter.During use, the Zipline 088 Access Catheter is advanced over a guidewire to the desired location in the neurovasculature. An outer catheter is then advanced over the Zipline 088 Access Catheter to the desired location. The Zipline 088 Access Catheter is a single lumen, variable stiffness catheter. It has a tapered flexible tip and a radiopaque marker at its distal end. Proximal to the tapered section is a “bulb” and a radiopaque coil to facilitate bulb visualization under fluoroscopy. The outer diameter of the bulb is designed to closely match the inner diameter of outer catheters, thereby minimizing the gap between the two catheters during navigation.The Zipline 088 Access Catheter has a hydrophilic coating on the outer surface of the distal end to enhance tracking through the vasculature. A luer fitting located on the catheter hub is used for attachment of ancillary devices. A continuous internal lumen spanning from the distal tip to the proximal hub accommodates guidewires up to 0.018” in diameter.

PERFUZE LIMITED

2024-11-30

Millipede 088 Access Catheter - The Millipede 088 Access Catheter consists of the catheter, a rotating hemostasis valve (RHV) and a valve crossing tool. The catheter, RHV and valve crossing tool are provided sterile. They are sterilized by ethylene oxide (EO). The Millipede 088 Access Catheter is a single lumen, coil-reinforced, variable stiffness catheter. The distal segment has a hydrophilic coating for navigation through the vasculature. The catheter has a radiopaque marker located at its distal end for visualization under fluoroscopy. The valve crossing tool is used to open the valve of the access sheath and to facilitate insertion of the Millipede 088 Access Catheter through the access sheath without damage. The RHV is assembled onto the hub of the Millipede 088 Access Catheter and is used to maintain hemostasis during infusion of saline and contrast agent and insertion of other devices through the Millipede 088 Access Catheter The Millipede 088 Access Catheter is indicated for use in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovasculature.

PERFUZE LIMITED

2023-12-18

Millipede 088 Access Catheter - The Millipede 088 Access Catheter consists of the catheter, a rotating hemostasis valve (RHV) and a valve crossing tool. The catheter, RHV and valve crossing tool are provided sterile. They are sterilized by ethylene oxide (EO).The Millipede 088 Access Catheter is a single lumen, coil-reinforced, variable stiffness catheter. The distal segment has a hydrophilic coating for navigation through the vasculature. The catheter has a radiopaque marker located at its distal end for visualization under fluoroscopy. The valve crossing tool is used to open the valve of the access sheath and to facilitate insertion of the Millipede 088 Access Catheter through the access sheath without damage. The RHV is assembled onto the hub of the Millipede 088 Access Catheter and is used to maintain hemostasis during infusion of saline and contrast agent and insertion of other devices through the Millipede 088 Access Catheter.

PERFUZE LIMITED

2023-11-02

Aspiration Tube Set - The Perfuze Aspiration Tube Set is a sterile, single-use device consisting of a single flexible braided tube. The tube has a rotating male luer-lock connector on the distal end and a suction connector on the proximal end. The rotating male luer-lock connector connects to the hub of a Millipede 070 Aspiration Catheter. The suction connector connects to the canister of an aspiration pump. A pinch clamp provides the user with the ability to apply vacuum to the catheter.

PERFUZE LIMITED

2023-11-02

Millipede 070 Aspiration Catheter - The Millipede 070 Aspiration Catheter is a sterile single-use device. It consists of the catheter and a rotating hemostasis valve (RHV).The catheter is a single lumen, reinforced, variable stiffness catheter. The distal segment has a hydrophilic coating for navigation through the vasculature. The catheter has a radiopaque marker located at its distal end for visualization under fluoroscopy. The RHV is assembled onto the hub of the catheter and is used to maintain hemostasis during infusion of saline and contrast agent and insertion of devices into the Millipede 070 Aspiration Catheter.For the aspiration source, the Millipede 070 Aspiration Catheter is used in conjunction with an compatible aspiration pump with prespecified performance parameters that is connected using the Perfuze Aspiration Tube Set along with a legally marketed canister and accessories kit.

PERFUZE LIMITED

2023-11-02

Millipede 088 Access Catheter - The Millipede 088 Access Catheter consists of the catheter, a rotating hemostasis valve (RHV) and a valve crossing tool. The catheter, RHV and valve crossing tool are provided sterile. They are sterilized by ethylene oxide (EO).The Millipede 088 Access Catheter is a single lumen, coil-reinforced, variable stiffness catheter. The distal segment has a hydrophilic coating for navigation through the vasculature. The catheter has a radiopaque marker located at its distal end for visualization under fluoroscopy. The valve crossing tool is used to open the valve of the access sheath and to facilitate insertion of the Millipede 088 Access Catheter through the access sheath without damage. The RHV is assembled onto the hub of the Millipede 088 Access Catheter and is used to maintain hemostasis during infusion of saline and contrast agent and insertion of other devices through the Millipede 088 Access CatheterThe Millipede 088 Access Catheter is indicated for use in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovasculature

PERFUZE LIMITED

2023-11-02