Cereglide
CEREGLIDE 71 is an intermediate catheter indicated to facilitate insertion and guidance of appropriately sized interventional devices into a selected neurovascular vessel. The filing also…
CEREGLIDE 71 is an intermediate catheter indicated to facilitate insertion and guidance of appropriately sized interventional devices into a selected neurovascular vessel. The filing also describes it as a conduit for retrieval devices.
The catheter has variable stiffness and a single lumen. It is packaged with a Tuohy-Borst rotating hemostasis valve with side port and two slit introducers. The valve supports flushing and catheter insertion, while the introducers help place the catheter into a base catheter and protect its distal tip.
Listed Item
CEREGLIDE 92 Catheter System CEREGLIDE 92 INNERGLIDE 9 130 cm 165 cm 0.092 in (2.34 mm) 0.030 in (0.76 mm) 0.102 in (2.59 mm) 0.042 in (1.07 mm) 0.108 in (2.74 mm) 0.078 in (1.98 mm) 0.113 in (2.87 mm) Minimum Guide Diameter
Catheter and Accessories
The FDA summary identifies the CEREGLIDE 71 as a neurovascular percutaneous catheter and states that the catheter and its accessories are for single use. The valve and introducers are packaged accessories described for catheter handling and insertion within the base catheter.
Who Else Makes It
Concentrated in Shanghai (4), Jiangsu (2). One is registered as a contract manufacturer, able to build to a specification.
| 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
| Listed by | Cerenovus, Inc., United States |
|---|---|
| FDA product code | QJP |
| Device type | Catheter, Percutaneous, Neurovasculature |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K221930 |
| Record published | 2024-06-20 |
| Record revised | 2026-01-26 (version 2) |
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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SBC92130UG | In distribution | |
| SBC92122UG | In distribution | |
| SBC92114UG | In distribution | |
| NIC71137U | In distribution | |
| SBC92135UG | In distribution | |
| CS71125U | In distribution | |
| NIC71115U | In distribution | |
| CS71132U | In distribution | |
| NIC57125U | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Saya 86 | Asahi Intecc Co., Ltd. | 12 |
| 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 |
| Marblehead Medical | Marblehead Medical, LLC | 4 |
Showing 12 of 54. All products under Catheter, Percutaneous, Neurovasculature
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K241244 | 2024-10-16 |
| K233982 | 2024-05-09 |
| K230726 | 2023-11-29 |
| K221930 | 2023-03-09 |
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.