| Primary Device ID | 05391539370067 |
| NIH Device Record Key | 0ca6fc0e-8295-4604-b1b0-b4a27f954fa9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Zipline 088 Access Catheter |
| Version Model Number | 1.0 |
| Catalog Number | PZA088147US |
| Company DUNS | 985715471 |
| Company Name | PERFUZE LIMITED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| 05391539370050 - Zipline 070 Access Catheter | 2024-12-09 The Zipline 070 Access Catheter is a single-use device designed to deliver large-bore catheters to the neurovasculature using st |
| 05391539370067 - Zipline 088 Access Catheter | 2024-12-09The 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. |
| 05391539370067 - Zipline 088 Access Catheter | 2024-12-09 The Zipline 088 Access Catheter is a single-use device designed to deliver large-bore catheters to the neurovasculature using st |
| 05391539370142 - Millipede 088 Access Catheter | 2023-12-26 The Millipede 088 Access Catheter consists of the catheter, a rotating hemostasis valve (RHV) and a valve crossing tool. The cat |
| 05391539370005 - Millipede 088 Access Catheter | 2023-11-10 The Millipede 088 Access Catheter consists of the catheter, a rotating hemostasis valve (RHV) and a valve crossing tool. The cat |
| 05391539370074 - Aspiration Tube Set | 2023-11-10 The Perfuze Aspiration Tube Set is a sterile, single-use device consisting of a single flexible braided tube. The tube has a rot |
| 05391539370098 - Millipede 070 Aspiration Catheter | 2023-11-10 The Millipede 070 Aspiration Catheter is a sterile single-use device. It consists of the catheter and a rotating hemostasis valv |
| 05391539370111 - Millipede 088 Access Catheter | 2023-11-10 The Millipede 088 Access Catheter consists of the catheter, a rotating hemostasis valve (RHV) and a valve crossing tool. The cat |