Nipro AQUALiner™
SUPER ELASTIC HYDROPHILIC Ni-Ti ALLOY GUIDEWIRE
10manufacturers in China registered for this device type
28catalogue numbers in this listing
2510(k) clearances naming this product code
5recalls on this 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 | Nipro Medical Corporation, United States |
|---|---|
| FDA product code | DQX |
| Device type | Wire, Guide, Catheter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1330 |
| Establishment | Complaint-file establishment, Exporter |
| Record published | 2016-09-16 |
| Record revised | 2018-03-29 (version 2) |
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, pack of 10 |
| Sizes | Length 150 to 260 cm; outer diameter 0.032 to 0.038 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ALS+35260AS | Length 260 cm | In distribution |
| ALS+38260SS | Outer Diameter 0.038 in | In distribution |
| ALS+35150SS | Length 150 cm | In distribution |
| ALS+35150SR | Outer Diameter 0.035 in | In distribution |
| ALS+38150SR | Length 150 cm | In distribution |
| ALS+38150SS | Outer Diameter 0.038 in | In distribution |
| ALS+38180SR | Length 180 cm | In distribution |
| ALS+35260SR | Outer Diameter 0.035 in | In distribution |
| ALS+38180AR | Outer Diameter 0.038 in | In distribution |
| ALS+35180AR | Length 180 cm | In distribution |
| ALS+32150AR | Length 150 cm | In distribution |
| ALS+35260AR | Length 260 cm | In distribution |
| ALS+35150AR | Length 150 cm | In distribution |
| ALS+38150AS | Outer Diameter 0.038 in | In distribution |
| ALS+38180SS | Length 180 cm | In distribution |
| ALS+32260SR | Outer Diameter 0.032 in | In distribution |
| ALS+38180AS | Outer Diameter 0.038 in | In distribution |
| ALS+35180SR | Outer Diameter 0.035 in | In distribution |
| ALS+35180AS | Length 180 cm | In distribution |
| ALS+38260SR | Length 260 cm | In distribution |
| ALS+38260AS | Length 260 cm | In distribution |
| ALS+35180SS | Outer Diameter 0.035 in | In distribution |
| ALS+32260AR | Outer Diameter 0.032 in | In distribution |
| ALS+35260SS | Length 260 cm | In distribution |
| ALS+38150AR | Outer Diameter 0.038 in | In distribution |
| ALS+32150SR | Outer Diameter 0.032 in | In distribution |
| ALS+35150AS | Outer Diameter 0.035 in | In distribution |
| ALS+38260AR | 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 |
| 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 |
|---|---|
| K003394 | 2001-01-30 |
| K001251 | 2000-07-07 |
Recalls
5 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2012-07-27 | Class II | Equipment maintenance | Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the wires contain insufficient lubricity which causes them to get stuck in the housing and become nonfunctional. | 400 | 2013-05-25 |
| 2012-07-27 | Class II | Equipment maintenance | Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the wires contain insufficient lubricity which causes them to get stuck in the housing and become nonfunctional. | 1500 | 2013-05-25 |
| 2012-07-27 | Class II | Equipment maintenance | Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the wires contain insufficient lubricity which causes them to get stuck in the housing and become nonfunctional. | 300 | 2013-05-25 |
| 2012-07-27 | Class II | Equipment maintenance | Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the wires contain insufficient lubricity which causes them to get stuck in the housing and become nonfunctional. | 100 | 2013-05-25 |
| 2012-07-27 | Class II | Equipment maintenance | Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the wires contain insufficient lubricity which causes them to get stuck in the housing and become nonfunctional. | 700 | 2013-05-25 |
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.