Asahi Gaia Next 2
2 catalogue numbers from AH14R320P, listed by Asahi Intecc Co., Ltd., Japan, under Wire, Guide, Catheter. 10 manufacturers in China are registered for this product code.
10manufacturers in China registered for this device type
2catalogue numbers in this listing
47510(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 | Asahi Intecc Co., Ltd., Japan |
|---|---|
| FDA product code | DQX |
| Device type | Wire, Guide, Catheter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1330 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2024-06-04 |
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 | Pack of 5 |
| Sizes | Outer diameter 0.014 in; length 190 to 300 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AH14R320P | Outer Diameter 0.014 in | In distribution |
| AH14R020P | Outer Diameter 0.014 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 |
| 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 |
|---|---|
| K243733 | 2025-04-02 |
| K241962 | 2025-03-27 |
| K242597 | 2025-03-05 |
| K241702 | 2025-02-06 |
| K241510 | 2024-08-14 |
| K240387 | 2024-06-21 |
| K230377 | 2023-07-20 |
| K213868 | 2022-09-06 |
| K213315 | 2022-07-01 |
| K211898 | 2021-12-08 |
| K192599 | 2020-01-02 |
| K191464 | 2019-11-21 |
| K190176 | 2019-08-01 |
| K183062 | 2019-07-01 |
| K180784 | 2018-07-18 |
| K173277 | 2018-07-05 |
| K171933 | 2018-02-12 |
| K163426 | 2017-04-03 |
| K162842 | 2017-01-27 |
| K161584 | 2016-10-06 |
| K153106 | 2016-06-21 |
| K153443 | 2016-02-25 |
| K150445 | 2015-06-30 |
| K141339 | 2014-10-23 |
| K133865 | 2014-03-18 |
| K122468 | 2013-03-08 |
| K122469 | 2013-03-08 |
| K113716 | 2012-02-06 |
| K101986 | 2011-09-09 |
| K101985 | 2011-03-07 |
| K103057 | 2010-11-19 |
| K100578 | 2010-09-22 |
| K083904 | 2009-01-29 |
| K083145 | 2009-01-12 |
| K083146 | 2008-11-21 |
| K070945 | 2008-01-09 |
| K072705 | 2007-10-23 |
| K072431 | 2007-09-26 |
| K071721 | 2007-07-13 |
| K063819 | 2007-01-26 |
| K062186 | 2006-11-09 |
| K061984 | 2006-10-05 |
| K052339 | 2005-11-30 |
| K052022 | 2005-08-25 |
| K043422 | 2005-01-12 |
| K041531 | 2004-08-03 |
| K032615 | 2003-09-16 |
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.