Fortrex
0.035 IN OTW PTA Balloon Catheter
5manufacturers in China registered for this device type
149catalogue 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) | K142654 |
| Record published | 2016-04-21 |
| Record revised | 2024-04-26 (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, expiry date |
| Storage | Special storage condition: Keep dry; Avoid direct sunlight |
| Packaging | Pack of 10 |
| Sizes | Outer diameter 4 to 12 mm; length 40 to 135 cm; catheter gauge 6 to 7 Fr |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A35HPV05080040 | Catheter Gauge 6 Fr | In distribution |
| A35HPV12080040 | Length 40 cm | In distribution |
| A35HPV06080135 | Outer Diameter 6.0 mm | In distribution |
| A35HPV08040080 | Outer Diameter 8 mm | In distribution |
| A35HPV05020080 | Length 80.0 cm | In distribution |
| A35HPV04100040 | Outer Diameter 4 mm | In distribution |
| A35HPV07080135 | Outer Diameter 7 mm | In distribution |
| A35HPV10040135 | Outer Diameter 10 mm | In distribution |
| A35HPV10080080 | Length 80 cm | In distribution |
| A35HPV06080080 | Length 80 cm | In distribution |
| A35HPV12080080 | Length 80 cm | In distribution |
| A35HPV07040135 | Outer Diameter 7.0 mm | In distribution |
| A35HPV08080040 | Catheter Gauge 6.0 Fr | In distribution |
| A35HPV04040080 | Catheter Gauge 6.0 Fr | In distribution |
| A35HPV06100080 | Max. Guidewire.89 MM | In distribution |
| A35HPV10040135 | Length 135.0 cm | In distribution |
| A35HPV07100080 | Length 80.0 cm | In distribution |
| A35HPV04100135 | Max. Guidewire.89 MM | In distribution |
| A35HPV08040040 | Length 40 cm | In distribution |
| A35HPV05040135 | Length 135.0 cm | In distribution |
| A35HPV07040080 | Max. Guidewire.89 MM | In distribution |
| A35HPV04020080 | Max. Guidewire.89 MM | In distribution |
| A35HPV12080135 | Outer Diameter 12 mm | In distribution |
| A35HPV06040135 | Catheter Gauge 6 Fr | In distribution |
| A35HPV10040080 | Length 80.0 cm | In distribution |
| A35HPV05020040 | Outer Diameter 5 mm | In distribution |
| A35HPV07100040 | Length 40 cm | In distribution |
| A35HPV10080135 | Catheter Gauge 7.0 Fr | In distribution |
| A35HPV08080135 | Outer Diameter 8 mm | In distribution |
| A35HPV09040080 | Length 80 cm | In distribution |
| A35HPV06020040 | Length 40 cm | In distribution |
| A35HPV08080040 | Length 40 cm | In distribution |
| A35HPV10040040 | Catheter Gauge 7.0 Fr | In distribution |
| A35HPV06020135 | Length 135 cm | In distribution |
| A35HPV05100080 | Outer Diameter 5 mm | In distribution |
| A35HPV08100135 | Length 135 cm | In distribution |
| A35HPV10080080 | Outer Diameter 10.0 mm | In distribution |
| A35HPV06080040 | Outer Diameter 6 mm | In distribution |
| A35HPV06100135 | Outer Diameter 6 mm | In distribution |
| A35HPV12040040 | Outer Diameter 12 mm | In distribution |
| A35HPV04100080 | Length 80 cm | In distribution |
| A35HPV04040040 | Outer Diameter 4 mm | In distribution |
| A35HPV08080080 | Length 80 cm | In distribution |
| A35HPV04080080 | Length 80.0 cm | In distribution |
| A35HPV07080080 | Outer Diameter 7.0 mm | In distribution |
| A35HPV12040080 | Length 80.0 cm | In distribution |
| A35HPV10040080 | Outer Diameter 10 mm | In distribution |
| A35HPV05100080 | Max. Guidewire.89 MM | In distribution |
| A35HPV08080080 | Length 80.0 cm | In distribution |
| A35HPV05040040 | Length 40 cm | In distribution |
| A35HPV07040040 | Catheter Gauge 6.0 Fr | In distribution |
| A35HPV04100080 | Outer Diameter 4.0 mm | In distribution |
| A35HPV05100135 | Catheter Gauge 6 Fr | In distribution |
| A35HPV06020080 | Catheter Gauge 6.0 Fr | In distribution |
| A35HPV05100135 | Outer Diameter 5.0 mm | In distribution |
| A35HPV07080040 | Max. Guidewire.89 MM | In distribution |
| A35HPV09080080 | Length 80 cm | In distribution |
| A35HPV05020135 | Outer Diameter 5.0 mm | In distribution |
| A35HPV07100080 | Outer Diameter 7 mm | In distribution |
| A35HPV12080135 | Outer Diameter 12.0 mm | In distribution |
| A35HPV12040080 | Outer Diameter 12 mm | In distribution |
| A35HPV05040040 | Length 40.0 cm | In distribution |
| A35HPV04080040 | Catheter Gauge 6 Fr | In distribution |
| A35HPV12040135 | Length 135.0 cm | In distribution |
| A35HPV09080135 | Catheter Gauge 7.0 Fr | In distribution |
| A35HPV12080040 | Max. Guidewire.89 MM | In distribution |
| A35HPV05020135 | Catheter Gauge 6.0 Fr | In distribution |
| A35HPV09080080 | Max. Guidewire.89 MM | In distribution |
| A35HPV05020080 | Outer Diameter 5 mm | In distribution |
| A35HPV08040080 | Outer Diameter 8.0 mm | In distribution |
| A35HPV08040135 | Outer Diameter 8 mm | In distribution |
| A35HPV04020135 | Length 135 cm | In distribution |
| A35HPV07100040 | Length 40.0 cm | In distribution |
| A35HPV09040135 | Max. Guidewire.89 MM | In distribution |
| A35HPV07100135 | Outer Diameter 7.0 mm | In distribution |
| A35HPV05080040 | Max. Guidewire.89 MM | In distribution |
| A35HPV06040080 | Length 80.0 cm | In distribution |
| A35HPV12040040 | Max. Guidewire.89 MM | In distribution |
| A35HPV07040080 | Length 80 cm | In distribution |
| A35HPV09080135 | Outer Diameter 9 mm | In distribution |
| A35HPV07080080 | Length 80 cm | In distribution |
| A35HPV10040040 | Length 40 cm | In distribution |
| A35HPV04040080 | Outer Diameter 4 mm | In distribution |
| A35HPV08040040 | Catheter Gauge 6.0 Fr | In distribution |
| A35HPV08100135 | Max. Guidewire.89 MM | In distribution |
| A35HPV05080080 | Length 80 cm | In distribution |
| A35HPV05020040 | Catheter Gauge 6.0 Fr | In distribution |
| A35HPV12040135 | Length 135 cm | In distribution |
| A35HPV08100040 | Outer Diameter 8.0 mm | In distribution |
| A35HPV05080080 | Length 80.0 cm | In distribution |
| A35HPV07040040 | Outer Diameter 7 mm | In distribution |
| A35HPV04080080 | Outer Diameter 4 mm | In distribution |
| A35HPV08100080 | Balloon Length,100,Millimeter;Wire Size,0.035,Inch;Nominal Pressure,9,AT;Rated Burst Pressure,18,AT; | In distribution |
| A35HPV07080135 | Length 135.0 cm | In distribution |
| A35HPV10080040 | Outer Diameter 10 mm | In distribution |
| A35HPV04020080 | Outer Diameter 4 mm | In distribution |
| A35HPV06080080 | Outer Diameter 6.0 mm | In distribution |
| A35HPV05100040 | Outer Diameter 5.0 mm | In distribution |
| A35HPV12080080 | Outer Diameter 12.0 mm | In distribution |
| A35HPV07040135 | Outer Diameter 7 mm | In distribution |
| A35HPV04020040 | Outer Diameter 4.0 mm | In distribution |
| A35HPV06040080 | Outer Diameter 6 mm | In distribution |
| A35HPV10080040 | Max. Guidewire.89 MM | In distribution |
| A35HPV06100040 | Length 40 cm | In distribution |
| A35HPV06040040 | Outer Diameter 6 mm | In distribution |
| A35HPV07020080 | Outer Diameter 7 mm | In distribution |
| A35HPV07020040 | Catheter Gauge 6 Fr | In distribution |
| A35HPV04080040 | Catheter Gauge 6.0 Fr | In distribution |
| A35HPV08100080 | Catheter Gauge 6.0 Fr | In distribution |
| A35HPV06020135 | Max. Guidewire.89 MM | In distribution |
| A35HPV04100135 | Outer Diameter 4 mm | In distribution |
| A35HPV05080135 | Max. Guidewire.89 MM | In distribution |
| A35HPV10080135 | Outer Diameter 10 mm | In distribution |
| A35HPV04100040 | Length 40.0 cm | In distribution |
| A35HPV06100135 | Outer Diameter 6.0 mm | In distribution |
| A35HPV09040040 | Catheter Gauge 7.0 Fr | In distribution |
| A35HPV09040040 | Length 40 cm | In distribution |
| A35HPV09040080 | Outer Diameter 9.0 mm | In distribution |
| A35HPV07080040 | Length 40 cm | In distribution |
| A35HPV04080135 | Outer Diameter 4.0 mm | In distribution |
| A35HPV04020135 | Length 135.0 cm | In distribution |
| A35HPV06100040 | Length 40.0 cm | In distribution |
| A35HPV07100135 | Outer Diameter 7 mm | In distribution |
| A35HPV06080135 | Length 135 cm | In distribution |
| A35HPV07020135 | Outer Diameter 7 mm | In distribution |
| A35HPV06020080 | Catheter Gauge 6 Fr | In distribution |
| A35HPV09080040 | Length 40 cm | In distribution |
| A35HPV05040080 | Outer Diameter 5.0 mm | In distribution |
| A35HPV06040040 | Max. Guidewire.89 MM | In distribution |
| A35HPV09040135 | Outer Diameter 9 mm | In distribution |
| A35HPV08040135 | Outer Diameter 8.0 mm | In distribution |
| A35HPV04020040 | Outer Diameter 4 mm | In distribution |
| A35HPV06040135 | Catheter Gauge 6.0 Fr | In distribution |
| A35HPV08080135 | Catheter Gauge 6.0 Fr | In distribution |
| A35HPV05040135 | Outer Diameter 5 mm | In distribution |
| A35HPV05040080 | Balloon Length,40,MM;Wire Size,0.035,IN | In distribution |
| A35HPV06080040 | Length 40.0 cm | In distribution |
| A35HPV04080135 | Length 135 cm | In distribution |
| A35HPV09080040 | Max. Guidewire.89 MM | In distribution |
| A35HPV05100040 | Outer Diameter 5 mm | In distribution |
| A35HPV07020040 | Max. Guidewire.89 MM | In distribution |
| A35HPV04040040 | Outer Diameter 4.0 mm | In distribution |
| A35HPV04040135 | Outer Diameter 4 mm | In distribution |
| A35HPV08100040 | Length 40 cm | In distribution |
| A35HPV06100080 | Outer Diameter 6 mm | In distribution |
| A35HPV07020135 | Outer Diameter 7.0 mm | In distribution |
| A35HPV04040135 | Catheter Gauge 6.0 Fr | In distribution |
| A35HPV06020040 | Catheter Gauge 6.0 Fr | In distribution |
| A35HPV05080135 | Outer Diameter 5 mm | 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.