AquaLiner

AquaLiner Hydrophilic Ni-Ti Alloy Guidewire, 3cm Straight Regular Tip

Registry build 21.09.26
10manufacturers in China registered for this device type
20catalogue numbers in this listing

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.

Chinese manufacturers registered for FDA product code DQX
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

Regulatory record for AquaLiner
Listed by AngioDynamics, Inc., United States
FDA product code DQX
Device type Wire, Guide, Catheter
Device class Class 2
Regulation 21 CFR 870.1330
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Record published 2016-09-20
Record revised 2021-09-28 (version 3)

Specifications

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, manufacturing date
Storage Storage environment temperature up to 27 °C
Packaging Box of 5
Sizes Outer diameter 0.035 in; length 150 to 260 cm
Distribution end date 2021-09-23

Catalogue Numbers

Catalogue numbers for AquaLiner
Catalogue number Size Status
60000101 Outer Diameter 0.035 in Withdrawn
60000302 Outer Diameter 0.035 in Withdrawn
60000203 Outer Diameter 0.035 in Withdrawn
60000202 Length 180 cm Withdrawn
60000104 Length 260 cm Withdrawn
60000304 Outer Diameter 0.035 in Withdrawn
60000205 Length 150 cm Withdrawn
60000103 Outer Diameter 0.035 in Withdrawn
60000003 Outer Diameter 0.035 in Withdrawn
60000301 Outer Diameter 0.035 in Withdrawn
60000004 Outer Diameter 0.035 in Withdrawn
60000305 Length 180 cm Withdrawn
60000201 Length 150 cm Withdrawn
60000102 Outer Diameter 0.035 in Withdrawn
60000002 Outer Diameter 0.035 in Withdrawn
60000208 Length 180 cm Withdrawn
60000204 Outer Diameter 0.035 in Withdrawn
60000207 Outer Diameter 0.035 in Withdrawn
60000001 Outer Diameter 0.035 in Withdrawn
60000303 Outer Diameter 0.035 in Withdrawn

Same Product Code

Other products under the same FDA 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

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer