Starter™ Guidewire
"J" Curved Moveable Core Guidewire
10manufacturers in China registered for this device type
82catalogue numbers in this listing
13510(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 | Lake Region Medical Limited, Ireland |
|---|---|
| FDA product code | DQX |
| Device type | Wire, Guide, Catheter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1330 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Record published | 2016-11-09 |
| Record revised | 2021-12-22 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 10, pack of 5, single pack sterile of 10 |
| Sizes | Length 40 to 260 cm; outer diameter 0.018 to 25 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M001492241 | Length 150 cm | In distribution |
| M001491771 | Outer Diameter 0.035 in | In distribution |
| M001491761 | Outer Diameter 0.038 in | In distribution |
| M001491231 | Outer Diameter 0.038 in | In distribution |
| M001491651 | Outer Diameter 0.035 in | In distribution |
| M001491381 | Outer Diameter 0.035 in | In distribution |
| M001492021 | Outer Diameter 0.025 in | In distribution |
| M001491001 | Outer Diameter 0.025 in | In distribution |
| M001491661 | Outer Diameter 0.038 in | In distribution |
| M001491341 | Length 260 cm | In distribution |
| M001491831 | Outer Diameter 0.038 in | In distribution |
| M001491311 | Outer Diameter 0.035 in | In distribution |
| M001492291 | Outer Diameter 0.035 in | In distribution |
| M001491451 | Outer Diameter 0.035 in | In distribution |
| M001491321 | Outer Diameter 0.035 in | In distribution |
| M001491191 | Outer Diameter 0.038 in | In distribution |
| M001491461 | In distribution | |
| M001491111 | Outer Diameter 0.038 in | In distribution |
| M001491811 | Outer Diameter 0.035 in | In distribution |
| M001491501 | Outer Diameter 0.035 in | In distribution |
| M001491391 | Outer Diameter 0.038 in | In distribution |
| M001492051 | In distribution | |
| M001492061 | Length 150 cm | In distribution |
| M001491161 | Outer Diameter 0.025 in | In distribution |
| M001492001 | Length 150 cm | In distribution |
| M001491101 | Outer Diameter 0.035 in | In distribution |
| M001492101 | Outer Diameter 0.035 in | In distribution |
| M001492381 | Outer Diameter 0.035 in | In distribution |
| M001491151 | Length 150 cm | In distribution |
| M001491551 | In distribution | |
| M001492201 | Outer Diameter 0.035 in | In distribution |
| M001491471 | Outer Diameter 0.035 in | In distribution |
| M001491851 | Outer Diameter 0.035 in | In distribution |
| M001492071 | Outer Diameter 0.032 in | In distribution |
| M001491571 | In distribution | |
| M001491361 | Outer Diameter 0.038 in | In distribution |
| M001491531 | In distribution | |
| M001491511 | In distribution | |
| M001491371 | Outer Diameter 0.035 in | In distribution |
| M001492351 | Outer Diameter 0.035 in | In distribution |
| M001492251 | Outer Diameter 0.035 in | In distribution |
| M001491691 | Outer Diameter 0.035 in | In distribution |
| M001491031 | Outer Diameter 0.035 in | In distribution |
| M001491181 | Length 150 cm | In distribution |
| M001492221 | Outer Diameter 0.035 in | In distribution |
| M001492361 | Length 150 cm | In distribution |
| M001492231 | Outer Diameter 0.035 in | In distribution |
| M001492261 | Outer Diameter 0.035 in | In distribution |
| M001491011 | Outer Diameter 0.035 in | In distribution |
| M001491681 | Outer Diameter 0.035 in | In distribution |
| M001491221 | Outer Diameter 0.035 in | In distribution |
| M001491601 | Outer Diameter 0.035 in | In distribution |
| M001491671 | Outer Diameter 0.035 in | In distribution |
| M001491331 | Outer Diameter 0.038 in | In distribution |
| M001491021 | Outer Diameter 0.038 in | In distribution |
| M001492081 | Outer Diameter 0.032 in | In distribution |
| M001492371 | Outer Diameter 0.018 in | In distribution |
| M001491201 | Outer Diameter 0.035 in | In distribution |
| M001491171 | Outer Diameter 0.035 in | In distribution |
| M001491561 | Outer Diameter 0.035 in | In distribution |
| M001492091 | Outer Diameter 0.035 in | In distribution |
| M001492111 | Outer Diameter 0.035 in | In distribution |
| M001491521 | Outer Diameter 0.035 in | In distribution |
| M001492011 | In distribution | |
| M001491611 | Outer Diameter 0.035 in | In distribution |
| M001491751 | Outer Diameter 0.035 in | In distribution |
| M001492271 | Outer Diameter 0.038 in | In distribution |
| M001491301 | Outer Diameter 0.035 in | In distribution |
| M001492031 | Outer Diameter 025 in | In distribution |
| M001491821 | Outer Diameter 0.035 in | In distribution |
| M001491351 | Outer Diameter 0.035 in | In distribution |
| M001492121 | Outer Diameter 0.035 in | In distribution |
| M001492501 | Length 150 cm | In distribution |
| M001492311 | Outer Diameter 0.035 in | In distribution |
| M001492131 | Outer Diameter 0.038 in | In distribution |
| M001492301 | Outer Diameter 0.035 in | In distribution |
| M001492141 | Outer Diameter 0.038 in | In distribution |
| M001491481 | Outer Diameter 0.035 in | In distribution |
| M001492211 | Outer Diameter 0.032 in | In distribution |
| M001491801 | Outer Diameter 0.035 in | In distribution |
| M001491701 | Outer Diameter 0.035 in | In distribution |
| M001492281 | Outer Diameter 0.038 in | 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 |
| INT,Falcon Guide Wire | Shanghai Kindly Medical Instruments Co., Ltd. | 72 |
| GuideRight™ | St. Jude Medical | 69 |
| INT, FirstWire | Shanghai Kindly Medical Instruments Co., Ltd. | 65 |
Showing 12 of 525. All products under Wire, Guide, Catheter
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253746 | 2026-03-19 |
| K242824 | 2024-12-06 |
| K221575 | 2022-10-07 |
| K211741 | 2021-11-22 |
| K160643 | 2016-10-18 |
| K151244 | 2015-06-11 |
| K140536 | 2014-12-17 |
| K142393 | 2014-11-25 |
| K133155 | 2014-04-07 |
| K140485 | 2014-03-27 |
| K130798 | 2013-08-23 |
| K112381 | 2011-11-03 |
| K111288 | 2011-08-02 |
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.