Lumax
Lumax Guiding Catheters are conduits introduced into a vein or artery, either singly or as a coaxial pair, and tracked over a wire guide toward a vascular lesion. Their stated use is to…
Lumax Guiding Catheters are conduits introduced into a vein or artery, either singly or as a coaxial pair, and tracked over a wire guide toward a vascular lesion.
Their stated use is to introduce interventional devices into peripheral vasculature, including pulmonary vasculature. Devices can pass through the guiding catheter’s internal lumen for treatment.
Listed Item
Lumax Guiding Catheter Guiding Coaxial Design
Device Construction
The filing describes a single catheter or an outer guiding catheter with an inner coaxial catheter. Single catheters have a 7 French outer diameter and are available in 80 or 90 centimeter lengths.
Who Else Makes It
Concentrated in Shanghai (5), Jiangsu (5), Guangdong (3). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
| Covidien Medical Products (Shanghai) Manufacturing LLC | Shanghai | Shanghai | Contract manufacturer | 8 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Goals Sterilization Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 26 |
| Wuxi Goals Medical Technology Co., Ltd. | Yixing | Jiangsu | Contract manufacturer | 24 |
| Suzhou Zenith Vascular Scitech Limited | Suzhou | Jiangsu | Manufacturer | 6 |
| Haolang Technology (Foshan) Limited Corporation | Foshan | Guangdong | Contract manufacturer | 6 |
| OrbusNeich Medical (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Complaint-file establishment | 5 |
| Curatia Medical Limited | Suzhou | Jiangsu | Specification developer | 5 |
| Shanghai Wallaby Medical Technologies Co., Inc. | Shanghai | Shanghai | Contract manufacturer | 5 |
| DK Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
Showing 12 of 14. All 14 manufacturers in China registered for Catheter, Percutaneous
Record
| Listed by | Cook Incorporated, United States |
|---|---|
| FDA product code | DQY |
| Device type | Catheter, Percutaneous |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K191163 |
| Record published | 2020-12-21 |
| Record revised | 2021-12-22 (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, manufacturing date |
| Storage | Special storage condition: Store in dark, dry, cool place. |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G47631 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Launcher™ | Medtronic, Inc. | 3,805 |
| Sherpa NX Balanced™ | Medtronic, Inc. | 1,523 |
| Arrow | Teleflex Medical LLC | 1,249 |
| Z2 | Medtronic, Inc. | 955 |
| Vista Brite TIP | Cordis Corp. | 789 |
| Mach1™ | Boston Scientific Corporation | 777 |
| Sherpa NX Active | Medtronic, Inc. | 571 |
| Zuma® | Medtronic, Inc. | 569 |
| Convey | Pendracare International B.V. | 532 |
| Taiga | Medtronic, Inc. | 307 |
| RunWay™ | Boston Scientific Corporation | 300 |
| ConcierGE Guiding Excellence™ | Merit Medical Systems, Inc. | 295 |
Showing 12 of 500. All products under Catheter, Percutaneous
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K191163 | 2019-12-12 |
| K150970 | 2015-05-12 |
| K131204 | 2014-01-29 |
| K122917 | 2013-06-28 |
| K122940 | 2013-03-19 |
| K101877 | 2010-08-06 |
| K091527 | 2009-06-12 |
| K090822 | 2009-04-27 |
| K073378 | 2007-12-28 |
| K063252 | 2006-11-14 |
| K052036 | 2005-08-25 |
| K033875 | 2004-04-02 |
| K032869 | 2003-11-19 |
| K032931 | 2003-10-22 |
| K031766 | 2003-06-26 |
| K022552 | 2002-09-27 |
| K990726 | 1999-04-02 |
| K914856 | 1992-05-01 |
| K902999 | 1991-02-01 |
| K902905 | 1990-09-04 |
| K851241 | 1986-02-26 |
| K832178 | 1983-08-12 |
Recalls
4 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. 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 |
|---|---|---|---|---|---|
| 2022-05-25 | Class II | Nonconforming Material/Component | The products may contain excess coating material on the outside and/or interior of the needle component. Potential adverse events that may occur if an affected product is used include a delay in the procedure, a prolonged procedure, or par | 11,451 units | |
| 2020-04-30 | Class II | Process control | The Pressure Monitoring Set and Tray may contain excess coating material on the outside and/or interior of the needle component which could cause occlusion. | 6792 | 2021-03-29 |
| 2020-04-30 | Class II | Process control | The Pressure Monitoring Set and Tray may contain excess coating material on the outside and/or interior of the needle component which could cause occlusion. | 1899 | 2021-03-29 |
| 2018-04-16 | Class II | Labeling mix-ups | Incorrect product labeling. Product labeled as 6mm x 2cm balloon are packaged with a 4mm x 4 cm balloon label and vice-versa. | 40 total products | 2019-06-27 |
| 2017-10-13 | Class II | Labeling Change Control | Label does not state that the product is heparin-coated. | 56 | 2019-10-23 |
| 2017-10-13 | Class II | Labeling Change Control | Label does not state that the product is heparin-coated. | 266 | 2019-10-23 |
| 2017-10-13 | Class II | Labeling Change Control | Label does not state that the product is heparin-coated. | 13 | 2019-10-23 |
| 2016-04-15 | Class II | Unknown/Undetermined by firm | Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications | 3,425 | 2017-08-04 |
| 2016-01-06 | Class I | Process control | A manufacturing process may lead to catheter tip fracture and or separation. Potential adverse events may include loss of device function, medical intervention to retrieve a separated segment, or complications resulting from a separated ti | 2280 | 2017-08-23 |
| 2016-01-06 | Class I | Process control | A manufacturing process may lead to catheter tip fracture and or separation. Potential adverse events may include loss of device function, medical intervention to retrieve a separated segment, or complications resulting from a separated ti | 12691 | 2017-08-23 |
| 2016-01-06 | Class I | Process control | A manufacturing process may lead to catheter tip fracture and or separation. Potential adverse events may include loss of device function, medical intervention to retrieve a separated segment, or complications resulting from a separated ti | 1341 | 2017-08-23 |
| 2016-01-06 | Class I | Process control | A manufacturing process may lead to catheter tip fracture and or separation. Potential adverse events may include loss of device function, medical intervention to retrieve a separated segment, or complications resulting from a separated ti | 1515 | 2017-08-23 |
| 2007-02-28 | Not classified | Other | Mislabeled as to size: The outer label reads 7-4.0 balloon, when the balloon is actually 5-2.0. | 20 units | 2007-05-29 |
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.