EverCross™
PTA AB35W12020080 Evercross 035 V10
14manufacturers in China registered for this device type
64catalogue numbers in this listing
15510(k) clearances naming this product code
7recalls 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 | Medtronic, Inc., United States |
|---|---|
| FDA product code | DQY |
| Device type | Catheter, Percutaneous |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K190753 |
| Record published | 2024-03-07 |
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: Keep away from sunlight; Special storage condition: Keep Dry |
| Sizes | Balloon diameter 3 to 12 mm; catheter working length 40 to 135 cm; balloon length 20 to 200 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AB35W12020080 | Balloon Diameter 12.0 mm | In distribution |
| AB35W06120040 | Minimum sheath inner diameter 5 FR | In distribution |
| AB35W05200080 | Minimum sheath inner diameter 5 FR | In distribution |
| AB35W03100080 | Balloon Length 100.0 mm | In distribution |
| AB35W05200135 | Balloon Diameter 5.0 mm | In distribution |
| AB35W05020040 | Balloon Length 20.0 mm | In distribution |
| AB35W07080135 | Minimum sheath inner diameter 6 FR | In distribution |
| AB35W06150135 | Minimum sheath inner diameter 5 FR | In distribution |
| AB35W04060080 | Balloon Diameter 4.0 mm | In distribution |
| AB35W12060135 | Minimum sheath inner diameter 7 FR | In distribution |
| AB35W07020080 | Minimum sheath inner diameter 5 FR | In distribution |
| AB35W07080080 | Balloon Diameter 7.0 mm | In distribution |
| AB35W06040135 | Catheter Working Length 135.0 cm | In distribution |
| AB35W08020040 | Minimum sheath inner diameter 6 FR | In distribution |
| AB35W07100135 | Catheter Working Length 135.0 cm | In distribution |
| AB35W05100135 | Minimum sheath inner diameter 5 FR | In distribution |
| AB35W03040135 | Minimum sheath inner diameter 5 FR | In distribution |
| AB35W06200080 | Minimum sheath inner diameter 6 FR | In distribution |
| AB35W08040080 | Catheter Working Length 80.0 cm | In distribution |
| AB35W03060135 | Balloon Diameter 3.0 mm | In distribution |
| AB35W07120135 | Minimum sheath inner diameter 6 FR | In distribution |
| AB35W08040135 | Balloon Length 40.0 mm | In distribution |
| AB35W04100135 | Catheter Working Length 135.0 cm | In distribution |
| AB35W03120135 | Balloon Length 120.0 mm | In distribution |
| AB35W07150080 | Minimum sheath inner diameter 6 FR | In distribution |
| AB35W09020135 | Catheter Working Length 135.0 cm | In distribution |
| AB35W07030080 | Catheter Working Length 80.0 cm | In distribution |
| AB35W04080135 | Minimum sheath inner diameter 5 FR | In distribution |
| AB35W09030135 | Balloon Length 30.0 mm | In distribution |
| AB35W03100135 | Minimum sheath inner diameter 5 FR | In distribution |
| AB35W07100080 | Balloon Length 100.0 mm | In distribution |
| AB35W09040135 | Balloon Diameter 9.0 mm | In distribution |
| AB35W07060080 | Minimum sheath inner diameter 6 FR | In distribution |
| AB35W03150135 | Balloon Diameter 3.0 mm | In distribution |
| AB35W08080080 | Catheter Working Length 80.0 cm | In distribution |
| AB35W05020135 | Balloon Length 20.0 mm | In distribution |
| AB35W03020135 | Minimum sheath inner diameter 5 FR | In distribution |
| AB35W04030135 | Minimum sheath inner diameter 5 FR | In distribution |
| AB35W12040135 | Catheter Working Length 135.0 cm | In distribution |
| AB35W04020080 | Balloon Diameter 4.0 mm | In distribution |
| AB35W06120135 | Catheter Working Length 135.0 cm | In distribution |
| AB35W06200135 | Balloon Diameter 6.0 mm | In distribution |
| AB35W05150080 | Catheter Working Length 80.0 cm | In distribution |
| AB35W08030135 | Minimum sheath inner diameter 6 FR | In distribution |
| AB35W12060080 | Catheter Working Length 80.0 cm | In distribution |
| AB35W08060135 | Minimum sheath inner diameter 6 FR | In distribution |
| AB35W07150135 | Catheter Working Length 135.0 cm | In distribution |
| AB35W07200135 | Balloon Diameter 7.0 mm | In distribution |
| AB35W09040080 | Balloon Diameter 9.0 mm | In distribution |
| AB35W05040080 | Balloon Length 40.0 mm | In distribution |
| AB35W03120080 | Minimum sheath inner diameter 5 FR | In distribution |
| AB35W06120080 | Minimum sheath inner diameter 5 FR | In distribution |
| AB35W05120040 | Balloon Length 120.0 mm | In distribution |
| AB35W07020040 | Minimum sheath inner diameter 5 FR | In distribution |
| AB35W08060080 | Minimum sheath inner diameter 6 FR | In distribution |
| AB35W07060040 | Balloon Diameter 7.0 mm | In distribution |
| AB35W04040080 | Balloon Diameter 4.0 mm | In distribution |
| AB35W05020080 | Catheter Working Length 80.0 cm | In distribution |
| AB35W05060040 | Minimum sheath inner diameter 5 FR | In distribution |
| AB35W06100080 | Balloon Length 100.0 mm | In distribution |
| AB35W06080040 | Balloon Diameter 6.0 mm | In distribution |
| AB35W06060080 | Catheter Working Length 80.0 cm | In distribution |
| AB35W10020080 | Minimum sheath inner diameter 6 FR | In distribution |
| AB35W08020080 | Minimum sheath inner diameter 6 FR | 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 |
|---|---|
| K253409 | 2025-12-19 |
| K250558 | 2025-03-27 |
| K223178 | 2022-11-08 |
| K222873 | 2022-11-07 |
| K192712 | 2020-08-03 |
| K183353 | 2019-03-22 |
| K183493 | 2019-03-15 |
| K132673 | 2013-10-22 |
| K121219 | 2012-09-25 |
| K112917 | 2011-10-27 |
| K103386 | 2011-02-11 |
| K101885 | 2010-09-09 |
| K090659 | 2009-03-26 |
| K080428 | 2008-12-09 |
| K082670 | 2008-12-04 |
Recalls
1 of these is 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 |
|---|---|---|---|---|---|
| 2022-04-20 | Class II | Under Investigation by firm | The firm’s internal processes identified that certain lots may have an improperly sealed barrier that could potentially compromise sterility. | 1385 devices | |
| 2021-09-09 | Class II | Under Investigation by firm | Medtronic is recalling three lots of unused C315HIS Delivery Catheters due to reports of an inability to pass a lead through the catheter. | 591 units | |
| 2017-09-26 | Class I | Nonconforming Material/Component | Complaints regarding 6F Taiga guide catheter tip detachment and/or tip splitting. | 15,923 | 2021-04-27 |
| 2013-06-12 | Class II | Labeling mix-ups | Medtronic has identified a labeling issue for 24 units of the Launcher coronary Guide Catheter. The two affected catheter lots are mislabeled and do not accurately reflect the catheters contained within each package. | 15 | 2013-11-19 |
| 2008-08-27 | Not classified | Process control | Medtronic has identified an issue with the packaging for specific lots of the Medtronic Adjustable Valve and valves contained in the Attain Left Heart Delivery System kits. A small number of valve package seals could be compromised. | 35,193 total | 2011-05-07 |
| 2008-08-27 | Not classified | Process control | Medtronic has identified an issue with the packaging for specific lots of the Medtronic Adjustable Valve and valves contained in the Attain Left Heart Delivery System kits. A small number of valve package seals could be compromised. | 35,193 total | 2011-05-07 |
| 2002-11-25 | Not classified | Other | An RF pulse occurs each time the temperature set point increase button is activated while ablating and this can result in heart rhythm disturbances. | 775 units | 2003-11-04 |
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.