87 NeuGlide Catheter

87 NeuGlide Catheter introduces interventional devices into peripheral, coronary and neurovascular anatomy. Its single-lumen tube combines metal coil or braid reinforcement with…

Registry build 21.09.26

87 NeuGlide Catheter introduces interventional devices into peripheral, coronary and neurovascular anatomy. Its single-lumen tube combines metal coil or braid reinforcement with medical-grade polymers and a proximal Luer fitting.

A hydrophilic coating supports tracking through tortuous vessels, and a soft distal tip assists passage at vessel branches. A distal radiopaque marker allows fluoroscopic localization. The catheter accepts guidewires up to 0.035 inch.

Listed Item

The 87 NeuGlide Catheter (103577-004) has an inner diameter of 0.087″ (6F compatible), a maximum outer diameter of 0.100″, and a working length of 100 cm.

Dimensions and Supply

The lumen is 0.087 inch in diameter and the maximum outer diameter is 0.100 inch. Working lengths are 100 or 110 cm. It is supplied sterile for single use with a loading tool for introducing the catheter into a short sheath.

6manufacturers in China registered for this device type
4catalogue numbers in this listing
3510(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 87 NeuGlide Catheter
Listed by Piraeus Medical, Inc., United States
FDA product code QJP
Device type Catheter, Percutaneous, Neurovasculature
Device class Class 2
Regulation 21 CFR 870.1250
Establishment Manufacturer
510(k) K240971
Record published 2025-07-15
Record revised 2025-06-10 (version 3)

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
Distribution end date 2025-01-02

Catalogue Numbers

Catalogue numbers for 87 NeuGlide Catheter
Catalogue number Size Status
103577-004 In distribution
103577-002 In distribution
100650-003 In distribution
103577-001 Withdrawn

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
ACCESS25 Delivery Microcatheter Penumbra Inc. 4
Midway Penumbra Inc. 4
Marblehead Medical Marblehead Medical, LLC 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
K262277 2026-09-04
K251044 2025-05-23
K240971 2024-12-06

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