EverCross
.035
5manufacturers in China registered for this device type
140catalogue numbers in this listing
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 | Covidien LP, United States |
|---|---|
| FDA product code | LIT |
| Device type | Catheter, Angioplasty, Peripheral, Transluminal |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| 510(k) | K103322 |
| Record published | 2015-10-12 |
| Record revised | 2023-12-11 (version 8) |
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: Keep dry |
| Sizes | Catheter gauge 5 to 7 Fr; outer diameter 3 to 12 mm; length 20 to 200 mm; length 40 to 80 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AB35W10030080 | Outer Diameter 10 mm | In distribution |
| AB35W07040135 | Catheter Gauge 5 Fr | In distribution |
| AB35W08020080 | Catheter Gauge 6 Fr | In distribution |
| AB35W05040080 | Working Length,80,Centimeter;Compatible Guidewire,0.035,Inch;Rated Burst Pressure,18,AT;Nominal Pressure,10,AT; | In distribution |
| AB35W05080080 | Length 80 mm | In distribution |
| AB35W06030135 | Working Length,135,Centimeter;Compatible Guidewire,0.035,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT; | In distribution |
| AB35W10060080 | Length 60 mm | In distribution |
| AB35W07150135 | Length 150 mm | In distribution |
| AB35W04040135 | Outer Diameter 4 mm | In distribution |
| AB35W07030135 | Working Length,135,Centimeter;Compatible Guidewire,0.035,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,7,AT; | In distribution |
| AB35W12040080 | Outer Diameter 12 mm | In distribution |
| AB35W05120080 | Outer Diameter 5 mm | In distribution |
| AB35W03030135 | Length 30 mm | In distribution |
| AB35W03040080 | Length 40 mm | In distribution |
| AB35W10040080 | Length 40 mm | In distribution |
| AB35W04020135 | Length 20 mm | In distribution |
| AB35W07150080 | Length 150 mm | In distribution |
| AB35W09030135 | Outer Diameter 9 mm | In distribution |
| AB35W07100080 | Length 100 mm | In distribution |
| AB35W12020135 | Length 20 mm | In distribution |
| AB35W08040080 | Outer Diameter 8 mm | In distribution |
| AB35W04150080 | Length 150 mm | In distribution |
| AB35W06200080 | Outer Diameter 6 mm | In distribution |
| AB35W07020080 | Length 20 mm | In distribution |
| AB35W03150080 | Working Length,80,Centimeter;Compatible Guidewire,0.035,Inch;Rated Burst Pressure,20,AT;Nominal Pressure,10,AT; | In distribution |
| AB35W05060040 | Outer Diameter 5 mm | In distribution |
| AB35W06040040 | Length 40 mm | In distribution |
| AB35W06120080 | Outer Diameter 6 mm | In distribution |
| AB35W05020135 | Outer Diameter 5 mm | In distribution |
| AB35W12020080 | Outer Diameter 12 mm | In distribution |
| AB35W08080080 | Length 80 mm | In distribution |
| AB35W03040135 | Outer Diameter 3 mm | In distribution |
| AB35W06020135 | Working Length,135,Centimeter;Compatible Guidewire,0.035,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT; | In distribution |
| AB35W03200135 | Catheter Gauge 5 Fr | In distribution |
| AB35W05030135 | Outer Diameter 5 mm | In distribution |
| AB35W05030040 | Outer Diameter 5 mm | In distribution |
| AB35W06060080 | Outer Diameter 6 mm | In distribution |
| AB35W06020040 | Catheter Gauge 5 Fr | In distribution |
| AB35W07020135 | Outer Diameter 7 mm | In distribution |
| AB35W08060040 | Length 60 mm | In distribution |
| AB35W08040040 | Length 40 mm | In distribution |
| AB35W08030135 | Length 30 mm | In distribution |
| AB35W06040135 | Working Length,135,Centimeter;Compatible Guidewire,0.035,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT; | In distribution |
| AB35W06030080 | Working Length,80,Centimeter;Compatible Guidewire,0.035,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT; | In distribution |
| AB35W07060135 | Length 60 mm | In distribution |
| AB35W05080135 | Outer Diameter 5 mm | In distribution |
| AB35W05060080 | Outer Diameter 5 mm | In distribution |
| AB35W05100080 | Outer Diameter 5 mm | In distribution |
| AB35W07020040 | Working Length,40,Centimeter;Compatible Guidewire,0.035,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,7,AT; | In distribution |
| AB35W03120135 | Outer Diameter 3 mm | In distribution |
| AB35W05020040 | Length 20 mm | In distribution |
| AB35W03150135 | Outer Diameter 3 mm | In distribution |
| AB35W06080040 | Outer Diameter 6 mm | In distribution |
| AB35W03200080 | Outer Diameter 3 mm | In distribution |
| AB35W03060135 | Length 60 mm | In distribution |
| AB35W06120040 | Outer Diameter 6 mm | In distribution |
| AB35W04150135 | Working Length,135,CM;Compatible Guidewire,0.035,IN;Rated Burst Pressure,20,AT;Nominal Pressure,10,AT | In distribution |
| AB35W08080135 | Outer Diameter 8 mm | In distribution |
| AB35W06200135 | Outer Diameter 6 mm | In distribution |
| AB35W05040040 | Length 40 mm | In distribution |
| AB35W07080080 | Length 80 mm | In distribution |
| AB35W04080135 | Catheter Gauge 5 Fr | In distribution |
| AB35W03080080 | Outer Diameter 3 mm | In distribution |
| AB35W07120080 | Length 120 mm | In distribution |
| AB35W07200080 | Catheter Gauge 6 Fr | In distribution |
| AB35W05200080 | Length 200 mm | In distribution |
| AB35W04080080 | Outer Diameter 4 mm | In distribution |
| AB35W04060135 | Outer Diameter 4 mm | In distribution |
| AB35W05200135 | Outer Diameter 5 mm | In distribution |
| AB35W04040080 | Catheter Gauge 5 Fr | In distribution |
| AB35W06040080 | Outer Diameter 6 mm | In distribution |
| AB35W07080135 | Working Length,135,Centimeter;Compatible Guidewire,0.035,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,7,AT; | In distribution |
| AB35W09020080 | Length 20 mm | In distribution |
| AB35W07100135 | Outer Diameter 7 mm | In distribution |
| AB35W07060080 | Outer Diameter 7 mm | In distribution |
| AB35W10030135 | Length 30 mm | In distribution |
| AB35W04100080 | Length 100 mm | In distribution |
| AB35W05020080 | Catheter Gauge 5 Fr | In distribution |
| AB35W04100135 | Length 100 mm | In distribution |
| AB35W07120135 | Outer Diameter 7 mm | In distribution |
| AB35W06060135 | Catheter Gauge 5 Fr | In distribution |
| AB35W09040135 | Length 40 mm | In distribution |
| AB35W06020080 | Working Length,80,Centimeter;Compatible Guidewire,0.035,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT; | In distribution |
| AB35W03060080 | Length 60 mm | In distribution |
| AB35W05080040 | Length 40 cm | In distribution |
| AB35W05060135 | Catheter Gauge 5 Fr | In distribution |
| AB35W12040135 | Length 40 mm | In distribution |
| AB35W09020135 | Length 20 mm | In distribution |
| AB35W05100135 | Length 100 mm | In distribution |
| AB35W06150135 | Catheter Gauge 5 Fr | In distribution |
| AB35W12060080 | Outer Diameter 12 mm | In distribution |
| AB35W04030135 | Outer Diameter 4 mm | In distribution |
| AB35W03080135 | Working Length,135,CM;Compatible Guidewire,0.035,IN;Rated Burst Pressure,20,AT;Nominal Pressure,10,AT | In distribution |
| AB35W03100135 | Catheter Gauge 5 Fr | In distribution |
| AB35W03100080 | Outer Diameter 3 mm | In distribution |
| AB35W04200135 | Length 200 mm | In distribution |
| AB35W03120080 | Outer Diameter 3 mm | In distribution |
| AB35W08020135 | Catheter Gauge 6 Fr | In distribution |
| AB35W09080080 | Outer Diameter 9 mm | In distribution |
| AB35W05120135 | Length 120 mm | In distribution |
| AB35W05120040 | Catheter Gauge 5 Fr | In distribution |
| AB35W08060135 | Outer Diameter 8 mm | In distribution |
| AB35W10040135 | Length 40 mm | In distribution |
| AB35W03020080 | Length 20 mm | In distribution |
| AB35W05030080 | Length 30 mm | In distribution |
| AB35W08040135 | Working Length,135,Centimeter;Compatible Guidewire,0.035,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,7,AT; | In distribution |
| AB35W08060080 | Length 60 mm | In distribution |
| AB35W03030080 | Outer Diameter 3 mm | In distribution |
| AB35W05150080 | Outer Diameter 5 mm | In distribution |
| AB35W07030080 | Outer Diameter 7 mm | In distribution |
| AB35W12060135 | Outer Diameter 12 mm | In distribution |
| AB35W03020135 | Length 20 mm | In distribution |
| AB35W07040080 | Outer Diameter 7 mm | In distribution |
| AB35W09030080 | Length 30 mm | In distribution |
| AB35W08030080 | Outer Diameter 8 mm | In distribution |
| AB35W10020135 | Length 20 mm | In distribution |
| AB35W04120135 | Length 120 mm | In distribution |
| AB35W04060080 | Outer Diameter 4 mm | In distribution |
| AB35W09080135 | Length 80 mm | In distribution |
| AB35W10060135 | Outer Diameter 10 mm | In distribution |
| AB35W04120080 | Outer Diameter 4 mm | In distribution |
| AB35W04020080 | Outer Diameter 4 mm | In distribution |
| AB35W05150135 | Length 150 mm | In distribution |
| AB35W05040135 | Catheter Gauge 5 Fr | In distribution |
| AB35W04030080 | Length 30 mm | In distribution |
| AB35W06100080 | Length 100 mm | In distribution |
| AB35W07200135 | Length 200 mm | In distribution |
| AB35W07040040 | Length 40 mm | In distribution |
| AB35W10020080 | Outer Diameter 10 mm | In distribution |
| AB35W06120135 | Outer Diameter 6 mm | In distribution |
| AB35W09060080 | Outer Diameter 9 mm | In distribution |
| AB35W09040080 | Outer Diameter 9 mm | In distribution |
| AB35W06080135 | Catheter Gauge 5 Fr | In distribution |
| AB35W06100135 | Catheter Gauge 5 Fr | In distribution |
| AB35W07060040 | Length 60 mm | In distribution |
| AB35W09060135 | Length 60 mm | In distribution |
| AB35W06150080 | Outer Diameter 6 mm | In distribution |
| AB35W04200080 | Outer Diameter 4 mm | In distribution |
| AB35W06080080 | Length 80 mm | In distribution |
| AB35W08020040 | Catheter Gauge 6 Fr | In distribution |
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 |
| EverCross™ | ev3, Inc. | 316 |
| Achilles NC PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 297 |
Showing 12 of 167. All products under Catheter, Angioplasty, Peripheral, Transluminal
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.