Journey™
4 catalogue numbers from M001391260, listed by Boston Scientific Corporation, United States, under Wire, Guide, Catheter. 10 manufacturers in China are registered for this product code.
10manufacturers in China registered for this device type
4catalogue numbers in this listing
37510(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 | Boston Scientific Corporation, United States |
|---|---|
| FDA product code | DQX |
| Device type | Wire, Guide, Catheter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1330 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-24 |
| Record revised | 2023-11-21 (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 |
| Distribution end date | 2020-05-20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M001391260 | 185 cm Effective Length | Withdrawn |
| M001391280 | 0.014 in Diameter | Withdrawn |
| M001391270 | 0.014 in Diameter | Withdrawn |
| M001391290 | 0.014 in Diameter | Withdrawn |
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 |
|---|---|
| K182315 | 2018-09-26 |
| K180726 | 2018-06-18 |
| K180795 | 2018-04-12 |
| K172453 | 2017-11-09 |
| K170636 | 2017-03-22 |
| K152231 | 2016-02-12 |
| K151840 | 2015-12-16 |
| K143587 | 2015-01-15 |
| K140673 | 2014-04-16 |
| K123024 | 2012-10-26 |
| K112745 | 2011-10-18 |
| K111485 | 2011-06-30 |
| K111498 | 2011-06-30 |
| K110479 | 2011-04-08 |
| K090554 | 2009-07-02 |
| K081021 | 2008-08-08 |
| K052783 | 2005-10-27 |
| K040867 | 2004-04-30 |
| K040140 | 2004-02-12 |
| K033742 | 2004-01-12 |
| K032050 | 2003-08-08 |
| K032183 | 2003-08-01 |
| K020283 | 2002-02-11 |
| K011906 | 2001-08-13 |
| K971688 | 1997-12-11 |
| K971254 | 1997-07-01 |
| K964611 | 1997-01-28 |
| K954622 | 1996-04-29 |
| K954552 | 1996-04-29 |
| K953023 | 1995-09-21 |
| K945379 | 1995-06-05 |
| K950352 | 1995-04-28 |
| K942453 | 1994-12-08 |
| K935997 | 1994-06-17 |
| K933334 | 1994-01-26 |
| K922302 | 1992-07-24 |
| K897152 | 1990-02-22 |
Recalls
2 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 |
|---|---|---|---|---|---|
| 2018-12-19 | Class II | Labeling mix-ups | A batch of 185cm Stingray Guidewires are incorrectly labeled as 300cm guidewires. | 49 units | 2020-06-09 |
| 2016-03-28 | Class II | Process control | Boston Scientific is voluntarily implementing a Medical Device Recall of one batch of PT Graphix Magnet J-TIP Guidewires. Boston Scientific has found that, while the batch is labeled as a J-tip model, the guidewires are straight and do not | 47 units | 2016-11-07 |
| 2011-08-01 | Not classified | Labeling mix-ups | Boston Scientific is voluntarily recalling one lot/batch of Katzen” Infusion Wires because we have identified that the label on the carton and the inner pouch indicated an incorrect device length. The labels indicate a device length of 18 | 33 | 2012-08-10 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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, 039 total units – all sizes | 2011-01-10 |
| 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 | |
| 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 |
| 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 | |
| 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 |
| 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 |
| 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 total units, all sizes | 2011-01-10 |
| 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 |
| 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 |
| 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 |
| 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 |
| 2010-04-19 | Not classified | Nonconforming Material/Component | Boston Scientific Corporation is conducting a Medical Device Recall of certain lots/batches of its Back-up Meier Steerable Guidewires. Through their internal inspection process, they identified that the polytetrafluoroethylene (PTFE) coat | US 885 single units (177 boxes), OUS 630 single units (126 b | 2011-12-10 |
| 2009-05-12 | Not classified | Process control | Product packaged incorrectly. One batch/lot of wires, that should contain radiopaque marker bands, is missing the marker bands; and a second batch/lot of wires, which should not contain radiopaque marker bands, has the marker bands. Since | Total of 5 boxes (5 units /box) , | 2011-12-11 |
| 2009-05-12 | Not classified | Process control | Product packaged incorrectly. One batch/lot of wires, that should contain radiopaque marker bands, is missing the marker bands; and a second batch/lot of wires, which should not contain radiopaque marker bands, has the marker bands. Since | Total of 4 boxes (5 units /box). | 2011-12-11 |
| 2008-08-25 | Not classified | Labeling mix-ups | Boston Scientific is initiating a voluntary recall of the Platinum Plus” Guidewire (peripheral). BSC has received reports that product may be labeled as a 260 CM long guidewire when the actual packaged device is a 180 CM long guidewire and | 35 | 2011-12-10 |
| 2008-08-25 | Not classified | Labeling mix-ups | Boston Scientific is initiating a voluntary recall of the Platinum Plus Guidewire (peripheral). BSC has received reports that product may be labeled as a 260 CM long guidewire when the actual packaged device is a 180 CM long guidewire and | 47 | 2011-12-10 |
| 2008-06-19 | Not classified | Process control | Boston Scientific is initiating a voluntary recall of the Platinum Plus Coronary Guidewire. Through our internal inspection process, we identified the potential that the PTFE (polytetrafluoroethylene) coating on the Platinum Plus Coronary G | 22,397 single units total (18,261 US, 4,136 OUS) | 2010-10-13 |
| 2008-06-19 | Not classified | Process control | Boston Scientific is initiating a voluntary recall of the Platinum Plus Coronary Guidewire. Through our internal inspection process, we identified the potential that the PTFE (polytetrafluoroethylene) coating on the Platinum Plus Coronary G | 22,397 single units total (18,261 US, 4,136 OUS) | 2010-10-13 |
| 2008-06-19 | Not classified | Process control | Boston Scientific is initiating a voluntary recall of the Platinum Plus Coronary Guidewire. Through our internal inspection process, we identified the potential that the PTFE (polytetrafluoroethylene) coating on the Platinum Plus Coronary G | 22,397 single units total (18,261 US, 4,136 OUS) | 2010-10-13 |
| 2008-06-19 | Not classified | Process control | Boston Scientific is initiating a voluntary recall of the Platinum Plus Coronary Guidewire. Through our internal inspection process, we identified the potential that the PTFE (polytetrafluoroethylene) coating on the Platinum Plus Coronary G | 22,397 single units total (18,261 US, 4,136 OUS) | 2010-10-13 |
| 2006-12-12 | Not classified | Other | Boston Scientific is voluntarily recalling one lot/batch of Katzen Infusion Wires because they have identified that the label on the carton may indicate a different length device than what is actually in the carton. The affected batch was | 10 units | 2007-07-20 |
| 2006-08-31 | Not classified | Other | The PT2 J-tip labeled guide wires may be missing the pre-formed J-tip. As a result, guide wires may have a straight tip instead of a pre-formed J-tip. | 3,654 total. 1,041-US, 2,613-Foreign | 2007-06-26 |
| 2006-08-31 | Not classified | Other | The PT2 J-tip labeled guide wires may be missing the pre-formed J-tip. As a result, guide wires may have a straight tip instead of a pre-formed J-tip. | 1,423 total. 168-US, 1,255-foreign | 2007-06-26 |
| 2006-08-31 | Not classified | Other | The PT2 J-tip labeled guide wires may be missing the pre-formed J-tip. As a result, guide wires may have a straight tip instead of a pre-formed J-tip. | 343 Total. 329-US, 14-Foreign | 2007-06-26 |
| 2006-08-31 | Not classified | Other | The PT2 J-tip labeled guide wires may be missing the pre-formed J-tip. As a result, guide wires may have a straight tip instead of a pre-formed J-tip. | 115 total. 103-US, 12-Foreign | 2007-06-26 |
| 2006-05-30 | Not classified | Other | Boston Scientific discovered through an internal inspection process that the PTFE (polytetrafluoroethylene) coating is not consistently adhering to the transition area of the distal end of the guide wires which may cause PTFE to flake off. | 1455 units total | 2007-06-28 |
| 2006-05-30 | Not classified | Other | Boston Scientific discovered through an internal inspection process that the PTFE (polytetrafluoroethylene) coating is not consistently adhering to the transition area of the distal end of the guide wires which may cause PTFE to flake off. | 1455 units total | 2007-06-28 |
| 2006-05-30 | Not classified | Other | Boston Scientific discovered through an internal inspection process that the PTFE (polytetrafluoroethylene) coating is not consistently adhering to the transition area of the distal end of the guide wires which may cause PTFE to flake off. | 1455 units total | 2007-06-28 |
| 2006-05-30 | Not classified | Other | Boston Scientific discovered through an internal inspection process that the PTFE (polytetrafluoroethylene) coating is not consistently adhering to the transition area of the distal end of the guide wires which may cause PTFE to flake off. | 1455 units total | 2007-06-28 |
| 2006-05-30 | Not classified | Other | Boston Scientific discovered through an internal inspection process that the PTFE (polytetrafluoroethylene) coating is not consistently adhering to the transition area of the distal end of the guide wires which may cause PTFE to flake off. | 1455 units total | 2007-06-28 |
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.