Synchro 2
Standard Pre-shaped Guidewire with Hydrophilic Coating
10manufacturers in China registered for this device type
8catalogue 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.
| 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 | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | DQX |
| Device type | Wire, Guide, Catheter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1330 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K053268 |
| Record published | 2016-09-21 |
| Record revised | 2018-07-06 (version 3) |
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 |
| Storage | Special storage condition: Store in cool, dry, dark place. |
| Sizes | Length 200 to 300 cm; outer diameter 0.014 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M00326310 | Length 300.0 cm | In distribution |
| M00326510 | Outer Diameter 0.014 in | In distribution |
| M00326520 | Outer Diameter 0.014 in | In distribution |
| M00326420 | Outer Diameter 0.014 in | In distribution |
| M00326010 | Outer Diameter 0.014 in | In distribution |
| M00326410 | Length 200.0 cm | In distribution |
| M00326110 | Length 200.0 cm | In distribution |
| M00326320 | Length 300.0 cm | 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
Recalls Naming This Product
21 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 |
|---|---|---|---|---|---|---|---|
| Stryker Neurovascular | 510(k) number | 2024-04-18 | Class II | Component design/selection | Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of backloading the guidewire through the optional introducer accessory. This issue is li | 373,246 | |
| Stryker Neurovascular | UDI-DI | 2018-06-08 | Class II | Employee error | The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correct. The correct values are 0.014in (0.36m | 13503 | 2021-04-28 |
| Stryker Neurovascular | UDI-DI | 2018-06-08 | Class II | Employee error | The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correct. The correct values are 0.014in (0.36m | 3720 | 2021-04-28 |
| Stryker Neurovascular | UDI-DI | 2018-06-08 | Class II | Employee error | 831 | 2021-04-28 | |
| Stryker Neurovascular | UDI-DI | 2018-06-08 | Class II | Employee error | The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correct. The correct values are 0.014in (0.36m | 107 | 2021-04-28 |
| Stryker Neurovascular | UDI-DI | 2018-06-08 | Class II | Employee error | The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correct. The correct values are 0.014in (0.36m | 21971 | 2021-04-28 |
| Stryker Neurovascular | UDI-DI | 2018-06-08 | Class II | Employee error | The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correct. The correct values are 0.014in (0.36m | 6269 | 2021-04-28 |
| Stryker Neurovascular | UDI-DI | 2018-06-08 | Class II | Employee error | The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correct. The correct values are 0.014in (0.36m | 2421 | 2021-04-28 |
| Stryker Neurovascular | UDI-DI | 2018-06-08 | Class II | Employee error | The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correct. The correct values are 0.014in (0.36m | 305 | 2021-04-28 |
| Boston Scientific Corporation | 510(k) number | 2010-06-07 | Not classified | Other | The Guidewire has the potential to flake off polytetrafluroethylene (PTFE) particulate, which has the potential to embolize and result in infarction when introduced into a patient’s circulatory system. | 36,049 units total – all sizes | 2011-01-10 |
| Boston Scientific Corporation | 510(k) number | 2010-06-07 | Not classified | Other | The Guidewire has the potential to flake off polytetrafluroethylene (PTFE) particulate, which has the potential to embolize and result in infarction when introduced into a patient’s circulatory system. | 36049 units, all sizes | 2011-01-10 |
| Boston Scientific Corporation | 510(k) number | 2010-06-07 | Not classified | Other | The Guidewire has the potential to flake off polytetrafluroethylene (PTFE) particulate, which has the potential to embolize and result in infarction when introduced into a patient’s circulatory system. | 36,049 units – all sizes | 2011-01-10 |
| Boston Scientific Corporation | 510(k) number | 2010-06-07 | Not classified | Other | The Guidewire has the potential to flake off polytetrafluroethylene (PTFE) particulate, which has the potential to embolize and result in infarction when introduced into a patient’s circulatory system. | 36, 049 total units – all sizes | 2011-01-10 |
| Boston Scientific Corporation | 510(k) number | 2010-06-07 | Not classified | Other | The Guidewire has the potential to flake off polytetrafluroethylene (PTFE) particulate, which has the potential to embolize and result in infarction when introduced into a patient’s circulatory system. | 36,049 total units, all sizes | 2011-01-10 |
| Boston Scientific Corporation | 510(k) number | 2010-06-07 | Not classified | Other | The Guidewire has the potential to flake off polytetrafluroethylene (PTFE) particulate, which has the potential to embolize and result in infarction when introduced into a patient’s circulatory system. | 36, 049 total units, all sizes | 2011-01-10 |
| Boston Scientific Corporation | 510(k) number | 2010-06-07 | Not classified | Other | The Guidewire has the potential to flake off polytetrafluroethylene (PTFE) particulate, which has the potential to embolize and result in infarction when introduced into a patient’s circulatory system. | 2011-01-10 | |
| Boston Scientific Corporation | 510(k) number | 2010-06-07 | Not classified | Other | The Guidewire has the potential to flake off polytetrafluroethylene (PTFE) particulate, which has the potential to embolize and result in infarction when introduced into a patient’s circulatory system. | 36, 049 total units, all sizes | 2011-01-10 |
| Boston Scientific Corporation | 510(k) number | 2010-06-03 | Not classified | Process design | Boston Scientific is initiating a Medical Device Recall regarding specific lots of the FathomTM-14 Steerable Guidewire. For lubricity, the distal portion of these guidewires is coated with hydrophilic polymer and the proximal portion is co | 469 units | 2011-12-10 |
| Boston Scientific Corporation | 510(k) number | 2010-06-03 | Not classified | Process design | Boston Scientific is initiating a Medical Device Recall regarding specific lots of the FathomTM-14 Steerable Guidewire. For lubricity, the distal portion of these guidewires is coated with hydrophilic polymer and the proximal portion is co | 164 units | 2011-12-10 |
| Boston Scientific Corporation | 510(k) number | 2010-06-03 | Not classified | Process design | Boston Scientific is initiating a Medical Device Recall regarding specific lots of the FathomTM-14 Steerable Guidewire. For lubricity, the distal portion of these guidewires is coated with hydrophilic polymer and the proximal portion is co | 34 units | 2011-12-10 |
| Boston Scientific Corporation | 510(k) number | 2010-06-03 | Not classified | Process design | Boston Scientific is initiating a Medical Device Recall regarding specific lots of the FathomTM-14 Steerable Guidewire. For lubricity, the distal portion of these guidewires is coated with hydrophilic polymer and the proximal portion is co | 78 units | 2011-12-10 |
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.