VSI
Guidewire, Amplatz, 0.035", 180cm, Straight
10manufacturers in China registered for this device type
35catalogue numbers in this listing
1510(k) clearance
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 | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | DQX |
| Device type | Wire, Guide, Catheter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1330 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2022-01-20 |
| Record revised | 2024-01-10 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 20 to 25 °C |
| Packaging | Pouch of 5, box of 5, box of 10, po of 5, pack of 10 |
| Sizes | Length 40 to 300 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN001655 | Length 180 cm | In distribution |
| IPN001653 | Length 80 cm | In distribution |
| IPN001646 | Length 150 cm | In distribution |
| IPN913168 | Length 60 cm | In distribution |
| IPN001654 | Length 150 cm | In distribution |
| IPN001630 | Length 180 cm | In distribution |
| IPN913173 | Length 80 cm | In distribution |
| IPN001649 | Length 150 cm | In distribution |
| IPN913185 | Length 80 cm | In distribution |
| IPN001659 | Length 260 cm | In distribution |
| IPN001644 | Length 145 cm | In distribution |
| IPN001626 | Length 90.0 cm | In distribution |
| IPN001647 | Length 180 cm | In distribution |
| IPN001651 | Length 260 cm | In distribution |
| IPN913171 | Length 40 cm | In distribution |
| IPN001645 | Length 300 cm | In distribution |
| IPN001656 | Length 260 cm | In distribution |
| IPN913169 | Length 40 cm | In distribution |
| IPN001650 | Length 180 cm | In distribution |
| IPN001615 | Length 60 cm | In distribution |
| IPN913184 | Length 60 cm | In distribution |
| IPN913181 | Length 40 cm | In distribution |
| IPN913175 | Length 40 cm | In distribution |
| IPN913183 | Length 60 cm | In distribution |
| IPN001648 | Length 260 cm | In distribution |
| IPN001631 | Length 150 cm | In distribution |
| IPN001658 | Length 180 cm | In distribution |
| IPN001657 | Length 150 cm | In distribution |
| IPN913174 | Length 100 cm | In distribution |
| IPN913172 | Length 130 cm | In distribution |
| IPN001652 | Length 300 cm | In distribution |
| IPN001629 | Length 260 cm | In distribution |
| IPN001628 | Length 145 cm | In distribution |
| IPN913182 | Length 40 cm | In distribution |
| IPN001627 | Length 90 cm | 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 |
|---|---|
| K241784 | 2024-09-18 |
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.