Cook
Australian Mandril Wire Guide Stainless Steel
10manufacturers in China registered for this device type
410catalogue numbers in this listing
26510(k) clearances naming this product code
40recalls 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 | Cook Incorporated, United States |
|---|---|
| FDA product code | DQX |
| Device type | Wire, Guide, Catheter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1330 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K171912 |
| Record published | 2016-09-24 |
| Record revised | 2021-12-22 (version 4) |
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. |
| Distribution end date | 2024-12-06 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G00530 | In distribution | |
| G00663 | In distribution | |
| G01974 | In distribution | |
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| G29437 | In distribution | |
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| G00808 | In distribution | |
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| G00626 | In distribution | |
| G01500 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arrow | Teleflex Medical LLC | 625 |
| 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 |
| 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 |
|---|---|
| K182985 | 2019-07-22 |
| K181353 | 2019-02-15 |
| K183467 | 2019-01-11 |
| K180830 | 2018-12-20 |
| K181351 | 2018-06-14 |
| K171997 | 2018-03-30 |
| K171912 | 2018-03-19 |
| K171764 | 2018-03-09 |
| K171445 | 2018-01-10 |
| K171948 | 2018-01-05 |
| K171897 | 2017-08-21 |
| K150802 | 2015-05-28 |
| K130766 | 2013-07-17 |
| K123707 | 2013-02-28 |
| K110163 | 2011-02-25 |
| K110009 | 2011-02-02 |
| K091385 | 2009-08-07 |
| K081337 | 2008-08-08 |
| K070410 | 2007-04-27 |
| K042611 | 2004-11-12 |
| K983771 | 1998-11-12 |
| K920891 | 1992-12-21 |
| K920824 | 1992-10-16 |
| K901899 | 1990-09-27 |
| K880722 | 1988-08-19 |
| K781393 | 1978-10-30 |
Recalls Naming This Product
9 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Cook Incorporated | 510(k) number | 2022-08-16 | Class II | Under Investigation by firm | Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised. | 150 US, 97 OUS | |
| Cook Incorporated | UDI-DI | 2022-08-16 | Class II | Under Investigation by firm | Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised. | 58 US; 5 OUS | |
| Cook Incorporated | UDI-DI | 2022-08-16 | Class II | Under Investigation by firm | Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised. | 9,903 US; 5,185 OUS | |
| Cook Incorporated | UDI-DI | 2022-08-16 | Class II | Under Investigation by firm | Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised. | 5,669 US; 5,286 OUS | |
| Cook Incorporated | 510(k) number | 2022-08-16 | Class II | Under Investigation by firm | Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised. | 25 US | |
| Cook Incorporated | UDI-DI | 2022-08-16 | Class II | Under Investigation by firm | Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised. | 149 US | |
| Cook Incorporated | UDI-DI | 2022-08-16 | Class II | Under Investigation by firm | Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised. | No distribution (Distribution Center only) | |
| Cook Incorporated | UDI-DI | 2022-08-16 | Class II | Under Investigation by firm | Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised. | ||
| Cook Incorporated | UDI-DI | 2020-10-22 | Class I | Process control | Affected product was dropped during manufacturing, which may result in a bent wire guide and/or the presence of loose foreign matter on the wire guide. | 61 units | 2021-09-02 |
Recalls
32 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 |
|---|---|---|---|---|
| 2026-03-05 | Class II | Incorrect or no expiration date | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | 49 units |
| 2026-03-05 | Class II | Incorrect or no expiration date | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | 15 units |
| 2026-03-05 | Class II | Incorrect or no expiration date | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | 75 units |
| 2024-10-14 | Class II | Labeling Change Control | Devices from the affected device lots have labels that state the incorrect expiration dates. | 10 units |
| 2024-10-08 | Class II | Labeling Change Control | Affected device lots have labels that state the incorrect expiration dates. | 5,953 US; 2,528 OUS |
| 2024-10-08 | Class II | Labeling Change Control | Affected device lots have labels that state the incorrect expiration dates. | 2,005 US; 1,145 OUS |
| 2022-08-16 | Class II | Under Investigation by firm | Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised. | 1,236 US |
| 2022-08-16 | Class II | Under Investigation by firm | Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised. | 488 US, 5 OUS |
| 2022-08-16 | Class II | Under Investigation by firm | Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised. | 363 US; 244 OUS |
| 2022-08-16 | Class II | Under Investigation by firm | Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised. | 2,748 US; 302 OUS |
| 2022-08-16 | Class II | Under Investigation by firm | Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised. | 43 OUS |
| 2022-08-16 | Class II | Under Investigation by firm | Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised. | 5571 US, 409 OUS |
| 2022-08-16 | Class II | Under Investigation by firm | Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised. | 202 US; 11 OUS |
| 2022-08-16 | Class II | Under Investigation by firm | Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised. | 204 OUS |
| 2022-08-16 | Class II | Under Investigation by firm | Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised. | 5041 US; 298 OUS |
| 2022-08-16 | Class II | Under Investigation by firm | Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised. | No distribution (Distribution Center only) |
| 2022-08-16 | Class II | Under Investigation by firm | Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised. | 115 US |
| 2022-08-16 | Class II | Under Investigation by firm | Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised. | 277 US; 138 OUS |
| 2022-08-16 | Class II | Under Investigation by firm | Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised. | 42 US |
| 2022-08-16 | Class II | Under Investigation by firm | Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised. | 1,501 US; 380 OUS |
| 2022-07-19 | Class II | Under Investigation by firm | Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised. | 30 units |
| 2022-07-19 | Class II | Under Investigation by firm | Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised. | 865 units |
| 2022-07-19 | Class II | Under Investigation by firm | Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised. | 496 units |
| 2022-07-19 | Class II | Under Investigation by firm | Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised. | 85 units |
| 2022-07-19 | Class II | Under Investigation by firm | Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised. | 585 units |
| 2022-07-19 | Class II | Under Investigation by firm | Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised. | 1450 units |
| 2022-07-19 | Class II | Under Investigation by firm | Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised. | 15 units |
| 2022-07-19 | Class II | Under Investigation by firm | Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised. | 35 units |
| 2022-07-19 | Class II | Under Investigation by firm | Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised. | 189 units |
| 2022-07-19 | Class II | Under Investigation by firm | Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised. | 5400 units |
| 2022-07-19 | Class II | Under Investigation by firm | Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised. | 75 units |
| 2022-07-19 | Class II | Under Investigation by firm | Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised. | 2407 units |
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.