TrailBlazer™
PS SC-035-135 Trailblazer V04
14manufacturers in China registered for this device type
27catalogue numbers in this listing
4510(k) clearances naming this product code
3recalls on this code
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 | ev3, Inc., United States |
|---|---|
| FDA product code | DQY |
| Device type | Catheter, Percutaneous |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K092299 |
| Record published | 2017-10-15 |
| Record revised | 2025-08-25 (version 11) |
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 |
| Storage | Special storage condition: Do Not Store in Direct Sunlight; Special storage condition: Keep Dry |
| Packaging | Pack of 5 |
| Sizes | Length 65 to 150 cm; outer diameter 0.36 to 1.04 mm; catheter gauge 4 to 5 Fr |
| Distribution end date | 2025-08-21 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SC-014-150 | Max. Guidewire 0.014 in | In distribution |
| SC-035-135 | Length 135.0 cm | In distribution |
| SC-035-090 | Length 90.0 cm | In distribution |
| SC-014-135 | Length 135.0 cm | In distribution |
| SC-035-150 | Length 150.0 cm | In distribution |
| SC-018-150 | Length 150.0 cm | In distribution |
| SC-035-135 | Outer Diameter 1.04 mm | In distribution |
| SC-018-150 | Length 150.0 cm | In distribution |
| SC-035-065 | Max. Guidewire 0.035 in | In distribution |
| SC-018-135 | Catheter Gauge 4.0 Fr | In distribution |
| SC-014-135 | Outer Diameter 0.36 mm | In distribution |
| SC-014-135 | Length 135.0 cm | In distribution |
| SC-018-090 | Length 90.0 cm | In distribution |
| SC-014-150 | Length 150.0 cm | In distribution |
| SC-035-135 | Length 135.0 cm | Withdrawn |
| SC-035-090 | Length 90.0 cm | Withdrawn |
| SC-035-150 | Length 150.0 cm | Withdrawn |
| SC-018-090 | Outer Diameter 0.46 mm | Withdrawn |
| SC-018-135 | Length 135.0 cm | Withdrawn |
| SC-018-135 | Outer Diameter 0.46 mm | Withdrawn |
| SC-014-150 | Outer Diameter 0.36 mm | Withdrawn |
| SC-035-065 | Length 65.0 cm | Withdrawn |
| SC-035-065 | Length 65.0 cm | Withdrawn |
| SC-035-150 | Length 150.0 cm | Withdrawn |
| SC-018-150 | Length 150.0 cm | Withdrawn |
| SC-035-090 | Outer Diameter 0.89 mm | Withdrawn |
| SC-018-090 | Length 90.0 cm | Withdrawn |
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 |
|---|---|
| K092299 | 2009-08-07 |
| K090849 | 2009-05-01 |
| K082854 | 2008-12-04 |
| K082579 | 2008-11-20 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| ev3, Inc. | 510(k) number | 2009-11-06 | Not classified | Component design/selection | Catheter may crack near the radiopaque marker band at the distal end of the device during use. Cracking of the catheter shaft in this location can result in material separation, and potential embolization. | 70 | 2011-01-05 |
Recalls
1 of these is 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 |
|---|---|---|---|---|---|
| 2014-04-09 | Class II | Labeling Change Control | Covidien is recalling 2 production lots of EverCross 0.035 PTA Balloon Catheter because of a product labeling error. There is a discrepancy in the PTA Balloon length and the delivery catheter length printed on the product labeling. | 39 units (31 OUS, 8 US) | 2014-10-06 |
| 2010-11-12 | Not classified | Process control | ev3 has determined that specific lots of the NanoCross.014 OTW PTA Dilatation catheters may crack or break during use. Cracking or breaking of the catheter shaft can result in the inability to inflate or deflate the balloon, and can resul | 4,962 (3,858 US; 1,104 OUS) | 2011-05-17 |
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.