EverCross™
PTA AB35W08040040 Evercross 035 V05
5manufacturers in China registered for this device type
316catalogue numbers in this listing
7510(k) clearances naming this product code
3recalls on this code
Who Else Makes It
Concentrated in Jiangsu (3), Guangdong (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| OrbusNeich Medical (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Complaint-file establishment | 5 |
| Curatia Medical Limited | Suzhou | Jiangsu | Specification developer | 5 |
| Brosmed Medical Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Kossel Medtech (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 4 |
| DK Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
Record
| Listed by | ev3, Inc., United States |
|---|---|
| FDA product code | LIT |
| Device type | Catheter, Angioplasty, Peripheral, Transluminal |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K103322 |
| Record published | 2016-04-24 |
| Record revised | 2022-09-22 (version 6) |
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 Dry; Special storage condition: Keep away from sunlight |
| Sizes | Catheter gauge 5 to 7 Fr; length 40 to 135 cm; length 20 to 200 mm; outer diameter 3 to 12 mm; catheter working length 40 to 135 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AB35W08040040 | Length 40.0 mm | In distribution |
| AB35W07200080 | Length 200.0 mm | In distribution |
| AB35W04030080 | 30 MM Balloon Length | In distribution |
| AB35W07060080 | Length 80.0 cm | In distribution |
| AB35W05080040 | Outer Diameter 5.0 mm | In distribution |
| AB35W05200135 | Outer Diameter 5.0 mm | In distribution |
| AB35W06080040 | 0.035 IN Max. Guidewire | In distribution |
| AB35W08080080 | 80 MM Balloon Length | In distribution |
| AB35W03020135 | Catheter Gauge 5.0 Fr | In distribution |
| AB35W08080135 | Outer Diameter 8.0 mm | In distribution |
| AB35W05120080 | Outer Diameter 5.0 mm | In distribution |
| AB35W04080080 | Catheter Gauge 5.0 Fr | In distribution |
| AB35W05200135 | 200 MM Balloon Length | In distribution |
| AB35W04030135 | 30 MM Balloon Length | In distribution |
| AB35W08040135 | Outer Diameter 8.0 mm | In distribution |
| AB35W04120080 | 120 MM Balloon Length | In distribution |
| AB35W03040135 | 0.035 IN Max. Guidewire | In distribution |
| AB35W07020135 | Outer Diameter 7.0 mm | In distribution |
| AB35W03100080 | Length 80.0 cm | In distribution |
| AB35W03080135 | 80 MM Balloon Length | In distribution |
| AB35W07200135 | 7 MM Balloon Diameter | In distribution |
| AB35W05060040 | Length 60.0 mm | In distribution |
| AB35W06120135 | 6 MM Balloon Diameter | In distribution |
| AB35W05060080 | Catheter Gauge 5.0 Fr | In distribution |
| AB35W09080135 | Outer Diameter 9.0 mm | In distribution |
| AB35W06060135 | Length 135.0 cm | In distribution |
| AB35W08020040 | Catheter Gauge 6.0 Fr | In distribution |
| AB35W06040135 | 40 MM Balloon Length | In distribution |
| AB35W06020040 | 0.035 IN Max. Guidewire | In distribution |
| AB35W05020080 | Outer Diameter 5.0 mm | In distribution |
| AB35W03150135 | Outer Diameter 3.0 mm | In distribution |
| AB35W07120135 | Length 120.0 mm | In distribution |
| AB35W07030080 | Catheter Working Length 80.0 cm | In distribution |
| AB35W10030080 | Catheter Working Length 80.0 cm | In distribution |
| AB35W03030080 | Outer Diameter 3.0 mm | In distribution |
| AB35W03080135 | Length 80.0 mm | In distribution |
| AB35W04200135 | 200 MM Balloon Length | In distribution |
| AB35W06030080 | Outer Diameter 6.0 mm | In distribution |
| AB35W03080080 | 80 MM Balloon Length | In distribution |
| AB35W07030135 | Length 30.0 mm | In distribution |
| AB35W07100135 | 100 MM Balloon Length | In distribution |
| AB35W03030135 | Length 135.0 cm | In distribution |
| AB35W04040135 | Length 135.0 cm | In distribution |
| AB35W05200080 | Outer Diameter 5.0 mm | In distribution |
| AB35W03150135 | 150 MM Balloon Length | In distribution |
| AB35W03200080 | Catheter Working Length 80.0 cm | In distribution |
| AB35W04020080 | 4 MM Balloon Diameter | In distribution |
| AB35W10030135 | Outer Diameter 10.0 mm | In distribution |
| AB35W06080040 | Outer Diameter 6.0 mm | In distribution |
| AB35W09020135 | 0.035 IN Max. Guidewire | In distribution |
| AB35W08020080 | Outer Diameter 8.0 mm | In distribution |
| AB35W05020135 | Outer Diameter 5.0 mm | In distribution |
| AB35W05020040 | Outer Diameter 5.0 mm | In distribution |
| AB35W04200135 | Outer Diameter 4.0 mm | In distribution |
| AB35W12060080 | Length 80.0 cm | In distribution |
| AB35W05030135 | Length 135.0 cm | In distribution |
| AB35W06120135 | Length 120.0 mm | In distribution |
| AB35W03040080 | Outer Diameter 3.0 mm | In distribution |
| AB35W07080080 | Length 80.0 mm | In distribution |
| AB35W07120135 | Length 135.0 cm | In distribution |
| AB35W06150080 | 0.035 IN Max. Guidewire | In distribution |
| AB35W07080135 | Length 80.0 mm | In distribution |
| AB35W04060080 | Outer Diameter 4.0 mm | In distribution |
| AB35W05040080 | Outer Diameter 5.0 mm | In distribution |
| AB35W09040080 | Catheter Gauge 6.0 Fr | In distribution |
| AB35W07020135 | Catheter Gauge 5.0 Fr | In distribution |
| AB35W06150135 | Length 150.0 mm | In distribution |
| AB35W08020080 | 0.89 MM Max. Guidewire | In distribution |
| AB35W07020080 | 7 MM Balloon Diameter | In distribution |
| AB35W05060135 | Outer Diameter 5.0 mm | In distribution |
| AB35W07060040 | Length 60.0 mm | In distribution |
| AB35W10030080 | Catheter Gauge 6.0 Fr | In distribution |
| AB35W04100080 | 100 MM Balloon Length | In distribution |
| AB35W08040080 | Outer Diameter 8.0 mm | In distribution |
| AB35W07060135 | 60 MM Balloon Length | In distribution |
| AB35W04020135 | 20 MM Balloon Length | In distribution |
| AB35W07020080 | Outer Diameter 7.0 mm | In distribution |
| AB35W10060135 | 60 MM Balloon Length | In distribution |
| AB35W07020040 | Outer Diameter 7.0 mm | In distribution |
| AB35W08020040 | Length 20.0 mm | In distribution |
| AB35W07200135 | Outer Diameter 7.0 mm | In distribution |
| AB35W07120080 | 0.035 IN Max. Guidewire | In distribution |
| AB35W12060135 | Length 60.0 mm | In distribution |
| AB35W07200135 | 200 MM Balloon Length | In distribution |
| AB35W07030080 | Length 30.0 mm | In distribution |
| AB35W03120135 | 0.035 IN Max. Guidewire | In distribution |
| AB35W03120135 | Outer Diameter 3.0 mm | In distribution |
| AB35W06020040 | Outer Diameter 6.0 mm | In distribution |
| AB35W06020080 | 20 MM Balloon Length | In distribution |
| AB35W07030080 | 30 MM Balloon Length | In distribution |
| AB35W05060135 | 60 MM Balloon Length | In distribution |
| AB35W09030135 | Length 30.0 mm | In distribution |
| AB35W09030080 | Length 30.0 mm | In distribution |
| AB35W03100080 | Length 100.0 mm | In distribution |
| AB35W05080040 | Catheter Gauge 5.0 Fr | In distribution |
| AB35W04100080 | Length 100.0 mm | In distribution |
| AB35W12060135 | Length 135.0 cm | In distribution |
| AB35W10040135 | Length 135.0 cm | In distribution |
| AB35W05040135 | Length 40.0 mm | In distribution |
| AB35W07150135 | Catheter Gauge 6.0 Fr | In distribution |
| AB35W03150135 | Catheter Gauge 5.0 Fr | In distribution |
| AB35W06150080 | Catheter Gauge 5.0 Fr | In distribution |
| AB35W05150080 | 5 MM Balloon Diameter | In distribution |
| AB35W06080040 | Catheter Working Length 40.0 cm | In distribution |
| AB35W04080135 | 80 MM Balloon Length | In distribution |
| AB35W04080135 | Outer Diameter 4.0 mm | In distribution |
| AB35W12040135 | Length 40.0 mm | In distribution |
| AB35W05200080 | 200 MM Balloon Length | In distribution |
| AB35W03200135 | 200 MM Balloon Length | In distribution |
| AB35W07100080 | Length 100.0 mm | In distribution |
| AB35W04080080 | Length 80.0 mm | In distribution |
| AB35W03060135 | 60 MM Balloon Length | In distribution |
| AB35W09040135 | Length 135.0 cm | In distribution |
| AB35W07080135 | 0.035 IN Max. Guidewire | In distribution |
| AB35W05120040 | Outer Diameter 5.0 mm | In distribution |
| AB35W09080080 | 80 MM Balloon Length | In distribution |
| AB35W05100135 | Length 100.0 mm | In distribution |
| AB35W05060080 | Length 60.0 mm | In distribution |
| AB35W05020040 | Length 40.0 cm | In distribution |
| AB35W08020135 | Catheter Gauge 6.0 Fr | In distribution |
| AB35W08060080 | Length 60.0 mm | In distribution |
| AB35W08030135 | Catheter Gauge 6.0 Fr | In distribution |
| AB35W03120080 | 3 MM Balloon Diameter | In distribution |
| AB35W06030135 | Outer Diameter 6.0 mm | In distribution |
| AB35W05030080 | Length 30.0 mm | In distribution |
| AB35W06200080 | Length 200.0 mm | In distribution |
| AB35W05080040 | Catheter Working Length 40.0 cm | In distribution |
| AB35W09030135 | Catheter Gauge 6.0 Fr | In distribution |
| AB35W05040080 | Catheter Gauge 5.0 Fr | In distribution |
| AB35W03200080 | Length 200.0 mm | In distribution |
| AB35W05200080 | 5 MM Balloon Diameter | In distribution |
| AB35W04040080 | Length 80.0 cm | In distribution |
| AB35W10020080 | 0.035 IN Max. Guidewire | In distribution |
| AB35W10030135 | 10 MM Balloon Diameter | In distribution |
| AB35W04060135 | 60 MM Balloon Length | In distribution |
| AB35W07100080 | Catheter Gauge 6.0 Fr | In distribution |
| AB35W05060080 | Catheter Gauge 5.0 Fr | In distribution |
| AB35W06080080 | 6 MM Balloon Diameter | In distribution |
| AB35W06120080 | Length 80.0 cm | In distribution |
| AB35W08080080 | Outer Diameter 8.0 mm | In distribution |
| AB35W04200080 | 200 MM Balloon Length | In distribution |
| AB35W04040080 | Length 40.0 mm | In distribution |
| AB35W05120135 | Length 120.0 mm | In distribution |
| AB35W12020135 | Catheter Working Length 135.0 cm | In distribution |
| AB35W06060080 | 0.035 IN Max. Guidewire | In distribution |
| AB35W10020135 | Length 135.0 cm | In distribution |
| AB35W06030135 | Length 135.0 cm | In distribution |
| AB35W08030080 | Length 30.0 mm | In distribution |
| AB35W06020135 | Catheter Working Length 135.0 cm | In distribution |
| AB35W09020080 | 0.035 IN Max. Guidewire | In distribution |
| AB35W03150080 | 0.035 IN Max. Guidewire | In distribution |
| AB35W09030080 | Catheter Gauge 6.0 Fr | In distribution |
| AB35W06080135 | Length 80.0 mm | In distribution |
| AB35W09020135 | Outer Diameter 9.0 mm | In distribution |
| AB35W06200135 | 0.035 IN Max. Guidewire | In distribution |
| AB35W09030080 | Catheter Gauge 6.0 Fr | In distribution |
| AB35W05120040 | Catheter Gauge 5.0 Fr | In distribution |
| AB35W05100080 | 100 MM Balloon Length | In distribution |
| AB35W07120080 | 7 MM Balloon Diameter | In distribution |
| AB35W09040080 | 9 MM Balloon Diameter | In distribution |
| AB35W04120080 | Length 80.0 cm | In distribution |
| AB35W08060040 | Outer Diameter 8.0 mm | In distribution |
| AB35W06100135 | 100 MM Balloon Length | In distribution |
| AB35W07040080 | 7 MM Balloon Diameter | In distribution |
| AB35W09080080 | 80 MM Balloon Length | In distribution |
| AB35W06120040 | 0.035 IN Max. Guidewire | In distribution |
| AB35W06030080 | 0.035 IN Max. Guidewire | In distribution |
| AB35W08020080 | Catheter Gauge 6.0 Fr | In distribution |
| AB35W03080080 | Length 80.0 mm | In distribution |
| AB35W04120135 | Outer Diameter 4.0 mm | In distribution |
| AB35W08080135 | Catheter Gauge 6.0 Fr | In distribution |
| AB35W08030135 | Length 30.0 mm | In distribution |
| AB35W09080135 | 0.035 IN Max. Guidewire | In distribution |
| AB35W05120135 | Catheter Gauge 5.0 Fr | In distribution |
| AB35W06040080 | 40 MM Balloon Length | In distribution |
| AB35W04030080 | Outer Diameter 4.0 mm | In distribution |
| AB35W06080135 | Length 135.0 cm | In distribution |
| AB35W08030080 | Length 80.0 cm | In distribution |
| AB35W05100135 | 100 MM Balloon Length | In distribution |
| AB35W04150080 | Length 150.0 mm | In distribution |
| AB35W04150135 | 150 MM Balloon Length | In distribution |
| AB35W04120080 | Outer Diameter 4.0 mm | In distribution |
| AB35W06150080 | Outer Diameter 6.0 mm | In distribution |
| AB35W04100135 | Outer Diameter 4.0 mm | In distribution |
| AB35W03060080 | 0.035 IN Max. Guidewire | In distribution |
| AB35W07080080 | 0.89 MM Max. Guidewire | In distribution |
| AB35W09080080 | Outer Diameter 9.0 mm | In distribution |
| AB35W08020135 | Outer Diameter 8.0 mm | In distribution |
| AB35W10060135 | Length 60.0 mm | In distribution |
| AB35W04100080 | 100 MM Balloon Length | In distribution |
| AB35W06060080 | Catheter Working Length 80.0 cm | In distribution |
| AB35W08040135 | 8 MM Balloon Diameter | In distribution |
| AB35W04030135 | Length 30.0 mm | In distribution |
| AB35W05120080 | Length 80.0 cm | In distribution |
| AB35W12020135 | Length 135.0 cm | In distribution |
| AB35W03030080 | Catheter Gauge 5.0 Fr | In distribution |
| AB35W05030080 | 5 MM Balloon Diameter | In distribution |
| AB35W06060080 | Outer Diameter 6.0 mm | In distribution |
| AB35W06100080 | Outer Diameter 6.0 mm | In distribution |
| AB35W03200080 | 0.035 IN Max. Guidewire | In distribution |
| AB35W03020080 | 20 MM Balloon Length | In distribution |
| AB35W06080080 | Length 80.0 mm | In distribution |
| AB35W09060080 | Catheter Gauge 6.0 Fr | In distribution |
| AB35W05030040 | Length 30.0 mm | In distribution |
| AB35W04200080 | 0.035 IN Max. Guidewire | In distribution |
| AB35W06040135 | Catheter Gauge 5.0 Fr | In distribution |
| AB35W07040080 | Length 40.0 mm | In distribution |
| AB35W07100135 | Length 100.0 mm | In distribution |
| AB35W07040135 | Length 135.0 cm | In distribution |
| AB35W04040135 | Outer Diameter 4.0 mm | In distribution |
| AB35W12020080 | 0.035 IN Max. Guidewire | In distribution |
| AB35W03150080 | Length 150.0 mm | In distribution |
| AB35W04150080 | 0.035 IN Max. Guidewire | In distribution |
| AB35W08040040 | Catheter Gauge 6.0 Fr | In distribution |
| AB35W05040040 | Outer Diameter 5.0 mm | In distribution |
| AB35W06020080 | Length 20.0 mm | In distribution |
| AB35W06060135 | Length 60.0 mm | In distribution |
| AB35W08060135 | Outer Diameter 8.0 mm | In distribution |
| AB35W05040040 | Length 40.0 cm | In distribution |
| AB35W05080080 | 0.035 IN Max. Guidewire | In distribution |
| AB35W06040135 | Length 40.0 mm | In distribution |
| AB35W06040080 | Length 40.0 mm | In distribution |
| AB35W04020135 | Outer Diameter 4.0 mm | In distribution |
| AB35W06020135 | 20 MM Balloon Length | In distribution |
| AB35W03040135 | Length 40.0 mm | In distribution |
| AB35W09020080 | Outer Diameter 9.0 mm | In distribution |
| AB35W10030080 | Outer Diameter 10.0 mm | In distribution |
| AB35W03200135 | Outer Diameter 3.0 mm | In distribution |
| AB35W07100135 | 0.035 IN Max. Guidewire | In distribution |
| AB35W12040080 | Length 40.0 mm | In distribution |
| AB35W07040040 | 0.035 IN Max. Guidewire | In distribution |
| AB35W03030135 | Length 30.0 mm | In distribution |
| AB35W07060135 | Outer Diameter 7.0 mm | In distribution |
| AB35W03040080 | Length 80.0 cm | In distribution |
| AB35W03020135 | Length 20.0 mm | In distribution |
| AB35W04040135 | 40 MM Balloon Length | In distribution |
| AB35W05060040 | Catheter Gauge 5.0 Fr | In distribution |
| AB35W05030135 | Length 30.0 mm | In distribution |
| AB35W05040040 | 5 MM Balloon Diameter | In distribution |
| AB35W06200135 | Length 200.0 mm | In distribution |
| AB35W06040040 | 40 MM Balloon Length | In distribution |
| AB35W05040135 | 5 MM Balloon Diameter | In distribution |
| AB35W05080080 | Length 80.0 mm | In distribution |
| AB35W03120080 | Outer Diameter 3.0 mm | In distribution |
| AB35W07150135 | Length 150.0 mm | In distribution |
| AB35W07150080 | Outer Diameter 7.0 mm | In distribution |
| AB35W07150080 | 150 MM Balloon Length | In distribution |
| AB35W10040135 | Outer Diameter 10.0 mm | In distribution |
| AB35W09060080 | Length 60.0 mm | In distribution |
| AB35W09040135 | Outer Diameter 9.0 mm | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Parafleet SC 018 PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 1,460 |
| Jade Plus PTA Balloon Dilatation Catheter / Jade Plus 18 OTW | OrbusNeich Medical (Shenzhen) Co., Ltd. | 832 |
| Jade PTA Balloon Dilatation Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | 667 |
| Parafleet SC 014 PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 572 |
| Minerva PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 504 |
| Advocate | Arravasc, Ltd. | 441 |
| Ultraverse® 035 PTA Dilatation Catheter | Bard Peripheral Vascular, Inc. | 361 |
| Polux PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 359 |
| Advance | Cook Incorporated | 355 |
| Pacific™ Plus | Medtronic, Inc. | 347 |
| Achilles NC PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 297 |
| Castor NC PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 297 |
Showing 12 of 167. All products under Catheter, Angioplasty, Peripheral, Transluminal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K141118 | 2014-07-18 |
| K132777 | 2013-09-26 |
| K130911 | 2013-05-24 |
| K123544 | 2013-02-12 |
| K110319 | 2011-04-14 |
| K103322 | 2010-12-06 |
| K093286 | 2009-11-13 |
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 | 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 |
Recalls
3 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 |
|---|---|---|---|---|---|
| 2024-12-10 | Class II | Process change control | There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific lots. | 5189 units | |
| 2020-08-26 | Class II | Under Investigation by firm | Labeling discrepancy for the Rated Burst Pressure (RBP) value. | 4286 devices | 2023-06-09 |
| 2016-03-29 | Class II | Labeling False and Misleading | Medtronic is conducting a voluntary Urgent Medical Device Recall of two lots of the PowerCross 0.018″ Over the Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter because the product is mislabeled. | 27 (25 US, 2 OUS) | 2017-05-19 |
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.