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…

Registry build 21.09.26

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.

6manufacturers in China registered for this device type
1catalogue number
5510(k) clearances naming this product code

Who Else Makes It

Concentrated in Shanghai (4), Jiangsu (2). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code QJP
Manufacturer City Province Registered as Device types
Covidien Medical Products (Shanghai) Manufacturing LLC Shanghai Shanghai Contract manufacturer 8
Sterigenics Shanghai ETO Ltd. Shanghai Shanghai Contract manufacturer 65
Steris Sterilization Technologies (Suzhou) Ltd Suzhou Jiangsu Contract manufacturer 44
Suzhou Zenith Vascular Scitech Limited Suzhou Jiangsu Manufacturer 6
Shanghai Wallaby Medical Technologies Co., Inc. Shanghai Shanghai Contract manufacturer 5
Shanghai Heartcare Medical Technology Corporation Limited Shanghai Shanghai Manufacturer 2

Record

Regulatory record for Zipline 088 Access Catheter
Listed by Perfuze, Ireland
FDA product code QJP
Device type Catheter, Percutaneous, Neurovasculature
Device class Class 2
Regulation 21 CFR 870.1250
Establishment Manufacturer
510(k) K240711
Record published 2024-11-30

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for Zipline 088 Access Catheter
Catalogue number Size Status
1.0 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Saya 86 Asahi Intecc Co., Ltd. 12
Cereglide Cerenovus, Inc. 9
Branchor X Asahi Intecc Co., Ltd. 9
Stellar Guide Catheter Balt USA, LLC 8
Esperance Shanghai Wallaby Medical Technologies Co., Inc. 6
Fubuki XF Asahi Intecc Co., Ltd. 5
Fubuki XF-R Asahi Intecc Co., Ltd. 4
Apro 45 Intermediate Catheter Alembic LLC 4
Apro 55 Intermediate Catheter Alembic LLC 4
87 NeuGlide Catheter Piraeus Medical, Inc. 4
ACCESS25 Delivery Microcatheter Penumbra Inc. 4
Midway Penumbra Inc. 4

Showing 12 of 54. All products under Catheter, Percutaneous, Neurovasculature

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K253901 2026-07-09
K240711 2024-10-17
K233648 2023-12-14
K231802 2023-09-19
K214048 2022-09-20

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer