Shinobi
SGW Shinobi Plus 300 CM
10manufacturers in China registered for this device type
4catalogue numbers in this listing
25510(k) clearances naming this product code
Who Else Makes It
Concentrated in Beijing (4), Jiangsu (3), Guangdong (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Mehow Innovative (Huizhou) Ltd. | Huizhou | Guangdong | Contract manufacturer | 11 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Suzhou Prosteri Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Sunny Medical Device (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Lepu Medical Technology (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
| Beijing Target Medical Technologies Inc. | Beijing | Beijing | Contract manufacturer | 7 |
| Suzhou Zenith Vascular Scitech Limited | Suzhou | Jiangsu | Manufacturer | 6 |
| Beijing Bywave Sensing Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
| Shanghai Achieva Medical Suzhou Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 2 |
| Deepintec Scientific Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
Record
| Listed by | Cordis Corp., United States |
|---|---|
| FDA product code | DQX |
| Device type | Wire, Guide, Catheter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1330 |
| 510(k) | K953760 |
| Record published | 2021-01-26 |
| Record revised | 2024-10-14 (version 3) |
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 |
| Packaging | Box |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 547214 | In distribution | |
| 547214X | In distribution | |
| 547114 | In distribution | |
| 547114X | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arrow | Teleflex Medical LLC | 625 |
| Cook | Cook Incorporated | 410 |
| Guidewire | Argon Medical Devices, Inc. | 173 |
| Medline Industries, Inc. | Medline Industries, Inc. | 151 |
| Guidewire | Galt Medical Corp. | 144 |
| Amplatz | Cook Incorporated | 128 |
| InQwire® | Merit Medical Systems, Inc. | 120 |
| Angiographic Guide Wire | Medtronic, Inc. | 94 |
| Glidewire | Terumo Corp. | 83 |
| Starter™ Guidewire | Lake Region Medical Limited | 82 |
| INT,Falcon Guide Wire | Shanghai Kindly Medical Instruments Co., Ltd. | 72 |
| GuideRight™ | St. Jude Medical | 69 |
Showing 12 of 525. All products under Wire, Guide, Catheter
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K040592 | 2004-12-17 |
| K994358 | 2000-01-13 |
| K974560 | 1998-05-11 |
| K973845 | 1998-01-05 |
| K962765 | 1997-02-21 |
| K963214 | 1996-11-13 |
| K963171 | 1996-11-07 |
| K962932 | 1996-10-25 |
| K953760 | 1995-11-07 |
| K952067 | 1995-07-20 |
| K950316 | 1995-04-14 |
| K943522 | 1994-12-19 |
| K943340 | 1994-09-16 |
| K930982 | 1994-02-24 |
| K930091 | 1993-04-07 |
| K925833 | 1993-02-12 |
| K923696 | 1993-02-03 |
| K923134 | 1992-10-26 |
| K914863 | 1991-12-18 |
| K905423 | 1991-03-01 |
| K902612 | 1990-12-03 |
| K894633 | 1989-10-17 |
| K873403 | 1988-03-22 |
| K791276 | 1979-07-24 |
| K790258 | 1979-02-23 |
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.