Cereglide
CEREGLIDE 71 INNERGLIDE 7 137 cm 165 cm 0.071 in (1.80 mm) 0.030 in (0.76 mm) 0.082 in (2.08 mm) 0.042 in (1.07 mm) 0.0825 in (2.10 mm) 0.059 in (1.50 mm) 0.085 in (2.16 mm) Minimum Guide…
CEREGLIDE 71 INNERGLIDE 7 137 cm 165 cm 0.071 in (1.80 mm) 0.030 in (0.76 mm) 0.082 in (2.08 mm) 0.042 in (1.07 mm) 0.0825 in (2.10 mm) 0.059 in (1.50 mm) 0.085 in (2.16 mm) Minimum Guide Diameter
Who Else Makes It
Concentrated in Shanghai (3), 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 |
Record
| Listed by | Cerenovus, Inc., United States |
|---|---|
| FDA product code | NRY |
| Device type | Catheter, Thrombus Retriever |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K241221 |
| Record published | 2025-09-26 |
| Record revised | 2023-09-15 (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 |
|---|---|---|
| NIC42144U | In distribution | |
| NIC71125U | In distribution | |
| NIC42125U | In distribution | |
| CS71137U | In distribution | |
| NIC57115U | In distribution | |
| NIC42152U | In distribution | |
| NIC42115U | In distribution | |
| CS71115U | In distribution | |
| NIC57137U | In distribution | |
| NIC42160U | In distribution | |
| NIC42132U | In distribution | |
| NIC71132U | In distribution | |
| NIC57132U | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Penumbra System | Penumbra Inc. | 100 |
| RED 43 | Penumbra Inc. | 18 |
| Solitaire™ X-Pack | Micro Therapeutics, Inc. | 14 |
| ACE | Penumbra Inc. | 14 |
| Raptor Aspiration Catheter | Balt USA, LLC | 13 |
| Solitaire™ | Micro Therapeutics, Inc. | 9 |
| Solitaire™ X | Micro Therapeutics, Inc. | 9 |
| RED 68 | Penumbra Inc. | 9 |
| Riptide™ | Micro Therapeutics, Inc. | 9 |
| Zoom™ Reperfusion Catheter | Imperative Care Inc. | 9 |
| CaptureTM | Micro Therapeutics, Inc. | 8 |
| Esperance | Shanghai Wallaby Medical Technologies Co., Inc. | 6 |
Showing 12 of 80. All products under Catheter, Thrombus Retriever
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K262398 | 2026-08-13 |
| K251828 | 2025-08-22 |
| K241221 | 2024-10-16 |
| K233988 | 2024-01-17 |
| K221934 | 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.