Nexus
49 catalogue numbers from X-9-18-T10-TC, listed by Micro Therapeutics, Inc., United States, under Device, Neurovascular Embolization. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
49catalogue numbers in this listing
11510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (2), Guangdong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Shanghai Wallaby Medical Technologies Co., Inc. | Shanghai | Shanghai | Contract manufacturer | 5 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Suzhou Prosteri Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Microport Neurotech (Shanghai) Co., Ltd. | Shanghai | Shanghai | Manufacturer | 2 |
Record
| Listed by | Micro Therapeutics, Inc., United States |
|---|---|
| FDA product code | HCG |
| Device type | Device, Neurovascular Embolization |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5950 |
| 510(k) | K050543 |
| Record published | 2015-10-16 |
| Record revised | 2021-02-05 (version 4) |
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 |
| Sizes | Outer diameter 2 to 18 mm; length 1 to 30 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| X-9-18-T10-TC | Length 18 cm | In distribution |
| X-10-30-T10-MC | Length 30 cm | In distribution |
| X-8-15-T10-MC | Length 15 cm | In distribution |
| X-4-5-T10-TC | Length 5 cm | In distribution |
| X-2-1-T10-HSS | Outer Diameter 2 mm | In distribution |
| X-6-20-T10-MC | Softness Grade,Soft,NA;Coil Diameter,0.010,Inches; | In distribution |
| X-10-20-T10-TC | Outer Diameter 10 mm | In distribution |
| X-8-16-T10-TC | Outer Diameter 8 mm | In distribution |
| X-3-8-T10-MC | Length 8 cm | In distribution |
| X-3-10-T10-HSS | Length 10 cm | In distribution |
| X-3-6-T10-HSS | Outer Diameter 3 mm | In distribution |
| X-7-30-T10-HSS | Outer Diameter 7 mm | In distribution |
| X-10-20-T10-MC | Outer Diameter 5.5 mm | In distribution |
| X-4-5-T10-MC | Length 5 cm | In distribution |
| X-2-4-T10-HSS | Length 4 cm | In distribution |
| X-3-8-T10-HSS | Length 8 cm | In distribution |
| X-12-23-T10-TC | Outer Diameter 12 mm | In distribution |
| X-7-21-T10-MC | Outer Diameter 7 mm | In distribution |
| X-9-28-T10-MC | Outer Diameter 5.5 mm | In distribution |
| X-7-15-T10-MC | Outer Diameter 7 mm | In distribution |
| X-5-10-T10-TC | Outer Diameter 5 mm | In distribution |
| X-3-4-T10-HSS | Softness Grade,Supersoft,NA;Coil Diameter,0.0095,Inches; | In distribution |
| X-6-12-T10-MC | Softness Grade,Standard,NA;Coil Diameter,0.011,Inches; | In distribution |
| X-5-15-T10-MC | Outer Diameter 3.5 mm | In distribution |
| X-2-6-T10-HSS | Softness Grade,Supersoft,NA;Coil Diameter,0.0095,Inches; | In distribution |
| X-4-8-T10-HSS | Outer Diameter 4 mm | In distribution |
| X-6-12-T10-TC | Outer Diameter 6.0 mm | In distribution |
| X-4-6-T10-HSS | Softness Grade,Supersoft,NA;Coil Diameter,0.0095,Inches; | In distribution |
| X-3-3-T10-HSS | Outer Diameter 3 mm | In distribution |
| X-3-2-T10-MC | Softness Grade,Soft,NA;Coil Diameter,0.010,Inches; | In distribution |
| X-5-15-T10-HSS | Softness Grade,Soft,NA;Coil Diameter,0.010,Inches; | In distribution |
| X-3-5-T10-MC | Softness Grade,Soft,NA;Coil Diameter,0.010,Inches; | In distribution |
| X-16-29-T10-TC | Outer Diameter 16 mm | In distribution |
| X-2-3-T10-HSS | Length 3 cm | In distribution |
| X-4-10-T10-MC | Length 10 cm | In distribution |
| X-9-18-T10-MC | Softness Grade,Soft,NA;Coil Diameter,0.010,Inches; | In distribution |
| X-4-10-T10-HSS | Length 10 cm | In distribution |
| X-2-8-T10-HSS | Outer Diameter 2 mm | In distribution |
| X-3-4-T10-TC | Softness Grade,Standard,NA;Coil Diameter,0.011,Inches; | In distribution |
| X-7-15-T10-TC | Length 15 cm | In distribution |
| X-10-30-T10-HSS | Length 30 cm | In distribution |
| X-2-2-T10-HSS | Outer Diameter 2 mm | In distribution |
| X-18-29-T10-TC | Outer Diameter 7.9 mm | In distribution |
| X-8-25-T10-MC | Outer Diameter 4.5 mm | In distribution |
| X-4-4-T10-HSS | Outer Diameter 4 mm | In distribution |
| X-5-10-T10-MC | Softness Grade,Soft,NA;Coil Diameter,0.010,Inches; | In distribution |
| X-6-20-T10-HSS | Outer Diameter 6 mm | In distribution |
| X-8-30-T10-HSS | Length 30 cm | In distribution |
| X-14-26-T10-TC | Softness Grade,Standard,NA;Coil Diameter,0.011,Inches; | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Optima Coil System | Balt USA, LLC | 307 |
| Penumbra Coil 400 | Penumbra Inc. | 268 |
| Smart Coil | Penumbra Inc. | 238 |
| Axium™ Detachable Coil System | Micro Therapeutics, Inc. | 234 |
| Numen | Microport Neurotech (Shanghai) Co., Ltd. | 223 |
| Axium™ Prime Detachable Coil System | Micro Therapeutics, Inc. | 141 |
| Barricade Coil System | Balt USA, LLC | 137 |
| Numen Helia | Microport Neurotech (Shanghai) Co., Ltd. | 129 |
| V-Trak | MicroVention, Inc. | 106 |
| HydroSoft Helical | MicroVention, Inc. | 94 |
| AxiumTM | Micro Therapeutics, Inc. | 89 |
| LP Coil System | Penumbra Inc. | 77 |
Showing 12 of 99. All products under Device, Neurovascular Embolization
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K060747 | 2007-04-24 |
| K060625 | 2006-04-20 |
| K051560 | 2005-06-28 |
| K051425 | 2005-06-22 |
| K050543 | 2005-04-27 |
| K041649 | 2004-07-16 |
| K040694 | 2004-03-25 |
| K033372 | 2004-01-09 |
| K032497 | 2003-09-25 |
| K031852 | 2003-08-20 |
| K030392 | 2003-07-21 |
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.