RapidCross
PTA Rapid Exchange Balloon Dilatation Catheter
5manufacturers in China registered for this device type
240catalogue 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) | K130911 |
| Record published | 2015-10-09 |
| Record revised | 2025-06-24 (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 | Length 20 to 210 mm; outer diameter 2 to 4 mm; catheter gauge 4 Fr |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A14BX025210170 | Length 210 mm | In distribution |
| A14BX030080090 | Outer Diameter 3.0 mm | In distribution |
| A14BX030060090 | Catheter Gauge 4.0 Fr | In distribution |
| A14BX035040090 | Length 40.0 mm | In distribution |
| A14BX030060170 | Length 60.0 mm | In distribution |
| A14BX035020090 | Length 20 mm | In distribution |
| A14BX020040170 | Catheter Gauge 4.0 Fr | In distribution |
| A14BX040210170 | Length 210.0 mm | In distribution |
| A14BX040210090 | Catheter Gauge 4.0 Fr | In distribution |
| A14BX035150090 | Outer Diameter 3.5 mm | In distribution |
| A14BX025120090 | Max. Guidewire 0.36 MM | In distribution |
| A14BX030210170 | Length 210.0 mm | In distribution |
| A14BX035020170 | Outer Diameter 3.5 mm | In distribution |
| A14BX035100090 | Outer Diameter 3.5 mm | In distribution |
| A14BX035060170 | Outer Diameter 3.5 mm | In distribution |
| A14BX040150090 | Outer Diameter 4 mm | In distribution |
| A14BX040210090 | Length 210 mm | In distribution |
| A14BX035060090 | Catheter Gauge 4.0 Fr | In distribution |
| A14BX025040090 | Catheter Gauge 4.0 Fr | In distribution |
| A14BX030120090 | Catheter Gauge 4.0 Fr | In distribution |
| A14BX035150170 | Outer Diameter 3.5 mm | In distribution |
| A14BX040120170 | Max. Guidewire 0.36 MM | In distribution |
| A14BX035020090 | Length 20.0 mm | In distribution |
| A14BX040020090 | Length 20 mm | In distribution |
| A14BX040080170 | Outer Diameter 4.0 mm | In distribution |
| A14BX025120170 | Length 120 mm | In distribution |
| A14BX025150170 | Max. Guidewire 0.36 MM | In distribution |
| A14BX030100170 | Length 100 mm | In distribution |
| A14BX025150090 | Length 150 mm | In distribution |
| A14BX040040090 | Length 40.0 mm | In distribution |
| A14BX030020170 | Length 20 mm | In distribution |
| A14BX025060170 | Length 60.0 mm | In distribution |
| A14BX030120170 | Outer Diameter 3.0 mm | In distribution |
| A14BX020210090 | Length 210 mm | In distribution |
| A14BX020150170 | Outer Diameter 2 mm | In distribution |
| A14BX040120090 | Length 120.0 mm | In distribution |
| A14BX035210170 | Outer Diameter 3.5 mm | In distribution |
| A14BX020060090 | Length 60.0 mm | In distribution |
| A14BX040060170 | Catheter Gauge 4.0 Fr | In distribution |
| A14BX025120090 | Outer Diameter 2.5 mm | In distribution |
| A14BX035080170 | Outer Diameter 3.5 mm | In distribution |
| A14BX020100090 | Length 100 mm | In distribution |
| A14BX030060090 | Length 60.0 mm | In distribution |
| A14BX035120170 | Working Length,170,Centimeter;Compatible Guidewire,0.014,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT; | In distribution |
| A14BX020020090 | Length 20.0 mm | In distribution |
| A14BX025060090 | Catheter Gauge 4 Fr | In distribution |
| A14BX035040090 | Outer Diameter 3.5 mm | In distribution |
| A14BX020040090 | Length 40 mm | In distribution |
| A14BX025040090 | Working Length,90,Centimeter;Compatible Guidewire,0.014,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT; | In distribution |
| A14BX035210170 | Max. Guidewire 0.36 MM | In distribution |
| A14BX035100170 | Catheter Gauge 4 Fr | In distribution |
| A14BX035150170 | Length 150.0 mm | In distribution |
| A14BX020060170 | Outer Diameter 2.0 mm | In distribution |
| A14BX040100170 | Length 100 mm | In distribution |
| A14BX030040090 | Outer Diameter 3.0 mm | In distribution |
| A14BX040040170 | Length 40.0 mm | In distribution |
| A14BX035040170 | Outer Diameter 3.5 mm | In distribution |
| A14BX040080090 | Outer Diameter 4.0 mm | In distribution |
| A14BX030150170 | Length 150 mm | In distribution |
| A14BX020020170 | Max. Guidewire 0.36 MM | In distribution |
| A14BX020060170 | Outer Diameter 2 mm | In distribution |
| A14BX035120170 | Length 120.0 mm | In distribution |
| A14BX020100170 | Length 100.0 mm | In distribution |
| A14BX025080170 | Length 80.0 mm | In distribution |
| A14BX035100170 | Outer Diameter 3.5 mm | In distribution |
| A14BX020020170 | Outer Diameter 2.0 mm | In distribution |
| A14BX040150170 | Length 150.0 mm | In distribution |
| A14BX040120090 | Length 120 mm | In distribution |
| A14BX030080170 | Outer Diameter 3 mm | In distribution |
| A14BX035060170 | Length 60.0 mm | In distribution |
| A14BX040150090 | Length 150.0 mm | In distribution |
| A14BX020150090 | Length 150.0 mm | In distribution |
| A14BX035100170 | Max. Guidewire 0.36 MM | In distribution |
| A14BX030100170 | Max. Guidewire 0.36 MM | In distribution |
| A14BX025020090 | Length 20 mm | In distribution |
| A14BX040080090 | Length 80.0 mm | In distribution |
| A14BX030040170 | Length 40.0 mm | In distribution |
| A14BX025040170 | Outer Diameter 2.5 mm | In distribution |
| A14BX025150090 | Length 150.0 mm | In distribution |
| A14BX030080170 | Length 80.0 mm | In distribution |
| A14BX035210090 | Catheter Gauge 4 Fr | In distribution |
| A14BX035080170 | Outer Diameter 3.5 mm | In distribution |
| A14BX025100170 | Catheter Gauge 4 Fr | In distribution |
| A14BX040120170 | Length 120.0 mm | In distribution |
| A14BX035210170 | Length 210 mm | In distribution |
| A14BX030210090 | Catheter Gauge 4.0 Fr | In distribution |
| A14BX030020170 | Length 20.0 mm | In distribution |
| A14BX020040170 | Length 40.0 mm | In distribution |
| A14BX025210090 | Max. Guidewire 0.36 MM | In distribution |
| A14BX040120170 | Length 120 mm | In distribution |
| A14BX030150170 | Length 150.0 mm | In distribution |
| A14BX035020170 | Catheter Gauge 4.0 Fr | In distribution |
| A14BX040060090 | Max. Guidewire 0.36 MM | In distribution |
| A14BX020150170 | Outer Diameter 2.0 mm | In distribution |
| A14BX020120090 | Working Length,90,Centimeter;Compatible Guidewire,0.014,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT; | In distribution |
| A14BX035080090 | Outer Diameter 3.5 mm | In distribution |
| A14BX020150170 | Max. Guidewire 0.36 MM | In distribution |
| A14BX040210090 | Length 210.0 mm | In distribution |
| A14BX020060090 | Length 60.0 mm | In distribution |
| A14BX025080170 | Outer Diameter 2.5 mm | In distribution |
| A14BX040020090 | Outer Diameter 4.0 mm | In distribution |
| A14BX040120090 | Max. Guidewire 0.36 MM | In distribution |
| A14BX020120090 | Length 120.0 mm | In distribution |
| A14BX025020170 | Outer Diameter 2.5 mm | In distribution |
| A14BX040040090 | Max. Guidewire 0.36 MM | In distribution |
| A14BX025150090 | Max. Guidewire 0.36 MM | In distribution |
| A14BX040100170 | Length 100.0 mm | In distribution |
| A14BX025120090 | Outer Diameter 2.5 mm | In distribution |
| A14BX025100090 | Length 100.0 mm | In distribution |
| A14BX030020170 | Length 20.0 mm | In distribution |
| A14BX020060170 | Max. Guidewire 0.36 MM | In distribution |
| A14BX040020090 | Outer Diameter 4.0 mm | In distribution |
| A14BX020210170 | Outer Diameter 2.0 – 1.5 MM | In distribution |
| A14BX040150170 | Outer Diameter 4.0 mm | In distribution |
| A14BX020020090 | Length 20.0 mm | In distribution |
| A14BX025040090 | Length 40.0 mm | In distribution |
| A14BX025020090 | Length 20.0 mm | In distribution |
| A14BX020040090 | Max. Guidewire 0.36 MM | In distribution |
| A14BX040060090 | Length 60 mm | In distribution |
| A14BX040210170 | Length 210.0 mm | In distribution |
| A14BX020080170 | Length 80 mm | In distribution |
| A14BX030080090 | Length 80.0 mm | In distribution |
| A14BX030210090 | Outer Diameter 3.0 mm | In distribution |
| A14BX030210170 | Outer Diameter 3.0 – 2.5 MM | In distribution |
| A14BX035100090 | Working Length,90,Centimeter;Compatible Guidewire,0.014,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT; | In distribution |
| A14BX040020170 | Outer Diameter 4.0 mm | In distribution |
| A14BX030020090 | Catheter Gauge 4.0 Fr | In distribution |
| A14BX035040170 | Length 40.0 mm | In distribution |
| A14BX035100090 | Catheter Gauge 4.0 Fr | In distribution |
| A14BX035060170 | Length 60.0 mm | In distribution |
| A14BX035150090 | Catheter Gauge 4.0 Fr | In distribution |
| A14BX025100170 | Outer Diameter 2.5 mm | In distribution |
| A14BX035040170 | Max. Guidewire 0.36 MM | In distribution |
| A14BX025150170 | Outer Diameter 2.5 mm | In distribution |
| A14BX025040170 | Outer Diameter 2.5 mm | In distribution |
| A14BX025210170 | Max. Guidewire 0.36 MM | In distribution |
| A14BX020100090 | Length 100.0 mm | In distribution |
| A14BX030020090 | Outer Diameter 3.0 mm | In distribution |
| A14BX030080090 | Outer Diameter 3 mm | In distribution |
| A14BX020120170 | Outer Diameter 2.0 mm | In distribution |
| A14BX020150090 | Length 150 mm | In distribution |
| A14BX030060170 | Length 60 mm | In distribution |
| A14BX025210090 | Catheter Gauge 4 Fr | In distribution |
| A14BX030040170 | Max. Guidewire 0.36 MM | In distribution |
| A14BX025080170 | Catheter Gauge 4.0 Fr | In distribution |
| A14BX025080090 | Length 80 mm | In distribution |
| A14BX025020090 | Length 20.0 mm | In distribution |
| A14BX035150090 | Catheter Gauge 4 Fr | In distribution |
| A14BX020210090 | Outer Diameter 2.0 mm | In distribution |
| A14BX040080170 | Max. Guidewire 0.36 MM; | In distribution |
| A14BX040060170 | Length 60.0 mm | In distribution |
| A14BX025080090 | Catheter Gauge 4.0 Fr | In distribution |
| A14BX030060090 | Length 60 mm | In distribution |
| A14BX020210170 | Length 210 mm | In distribution |
| A14BX040080090 | Outer Diameter 4 mm | In distribution |
| A14BX035080170 | Working Length,170,Centimeter;Compatible Guidewire,0.014,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT; | In distribution |
| A14BX030020090 | Length 20 mm | In distribution |
| A14BX020210090 | Max. Guidewire 0.36 MM | In distribution |
| A14BX025150170 | Length 150.0 mm | In distribution |
| A14BX025210090 | Length 210.0 mm | In distribution |
| A14BX040040090 | Outer Diameter 4 mm | In distribution |
| A14BX030040090 | Outer Diameter 3 mm | In distribution |
| A14BX035210090 | Outer Diameter 3.5 – 3.0 MM | In distribution |
| A14BX030150090 | Outer Diameter 3 mm | In distribution |
| A14BX035120090 | Length 120.0 mm | In distribution |
| A14BX035210090 | Length 210.0 mm | In distribution |
| A14BX035060090 | Outer Diameter 3.5 mm | In distribution |
| A14BX040100090 | Max. Guidewire 0.36 MM | In distribution |
| A14BX025060170 | Outer Diameter 2.5 mm | In distribution |
| A14BX040100090 | Length 100 mm | In distribution |
| A14BX020100090 | Length 100.0 mm | In distribution |
| A14BX035040090 | Length 40 mm | In distribution |
| A14BX035020170 | Length 20.0 mm | In distribution |
| A14BX020080170 | Length 80.0 mm | In distribution |
| A14BX035060090 | Outer Diameter 3.5 mm | In distribution |
| A14BX030120170 | Length 120 mm | In distribution |
| A14BX025100090 | Outer Diameter 2.5 mm | In distribution |
| A14BX040150170 | Catheter Gauge 4 Fr | In distribution |
| A14BX040040170 | Outer Diameter 4 mm | In distribution |
| A14BX040150090 | Outer Diameter 4.0 mm | In distribution |
| A14BX030100090 | Length 100 mm | In distribution |
| A14BX040060090 | Outer Diameter 4.0 mm | In distribution |
| A14BX020080090 | Outer Diameter 2 mm | In distribution |
| A14BX020080170 | Outer Diameter 2.0 mm | In distribution |
| A14BX020100170 | Length 100.0 mm | In distribution |
| A14BX030150090 | Outer Diameter 3.0 mm | In distribution |
| A14BX040100170 | Outer Diameter 4.0 mm | In distribution |
| A14BX020020170 | Outer Diameter 2 mm | In distribution |
| A14BX035120170 | Outer Diameter 3.5 mm | In distribution |
| A14BX030080170 | Catheter Gauge 4.0 Fr | In distribution |
| A14BX025100170 | Length 100.0 mm | In distribution |
| A14BX030210090 | Length 210 mm | In distribution |
| A14BX020210170 | Length 210.0 mm | In distribution |
| A14BX020120090 | Length 120.0 mm | In distribution |
| A14BX040020170 | Catheter Gauge 4.0 Fr | In distribution |
| A14BX035120090 | Length 120 mm | In distribution |
| A14BX030120090 | Catheter Gauge 4 Fr | In distribution |
| A14BX030100090 | Length 100.0 mm | In distribution |
| A14BX020020090 | Length 20 mm | In distribution |
| A14BX035020090 | Outer Diameter 3.5 mm | In distribution |
| A14BX030060170 | Outer Diameter 3.0 mm | In distribution |
| A14BX040210170 | Length 210 mm | In distribution |
| A14BX030210170 | Length 210 mm | In distribution |
| A14BX025020170 | Length 20.0 mm | In distribution |
| A14BX040060170 | Outer Diameter 4 mm | In distribution |
| A14BX035120090 | Outer Diameter 3.5 mm | In distribution |
| A14BX020120170 | Max. Guidewire 0.36 MM | In distribution |
| A14BX025040170 | Max. Guidewire 0.36 MM | In distribution |
| A14BX025080090 | Length 80.0 mm | In distribution |
| A14BX030040090 | Catheter Gauge 4.0 Fr | In distribution |
| A14BX040040170 | Outer Diameter 4.0 mm | In distribution |
| A14BX035080090 | Outer Diameter 3.5 mm | In distribution |
| A14BX025060090 | Length 60.0 mm | In distribution |
| A14BX025100090 | Length 100.0 mm | In distribution |
| A14BX025020170 | Outer Diameter 2.5 mm | In distribution |
| A14BX040100090 | Outer Diameter 4.0 mm | In distribution |
| A14BX030120170 | Outer Diameter 3.0 mm | In distribution |
| A14BX035080090 | Outer Diameter 3.5 mm | In distribution |
| A14BX030120090 | Length 120.0 mm | In distribution |
| A14BX020150090 | Outer Diameter 2.0 mm | In distribution |
| A14BX020080090 | Catheter Gauge 4.0 Fr | In distribution |
| A14BX020040090 | Outer Diameter 2.0 mm | In distribution |
| A14BX040020170 | Working Length,170,Centimeter;Compatible Guidewire,0.014,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT; | In distribution |
| A14BX020040170 | Working Length,170,Centimeter;Compatible Guidewire,0.014,Inch;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT; | In distribution |
| A14BX025060090 | Length 60.0 mm | In distribution |
| A14BX030040170 | Outer Diameter 3 mm | In distribution |
| A14BX025210170 | Outer Diameter 2.5 mm | In distribution |
| A14BX020080090 | Outer Diameter 2.0 mm | In distribution |
| A14BX025120170 | Length 120.0 mm | In distribution |
| A14BX040080170 | Outer Diameter 4 mm | In distribution |
| A14BX020120170 | Length 120 mm | In distribution |
| A14BX020060090 | Length 60 mm | In distribution |
| A14BX030100090 | Outer Diameter 3.0 mm | In distribution |
| A14BX030100170 | Outer Diameter 3.0 mm | In distribution |
| A14BX025060170 | Outer Diameter 2.5 mm | In distribution |
| A14BX025120170 | Catheter Gauge 4.0 Fr | In distribution |
| A14BX020100170 | Length 100 mm | In distribution |
| A14BX035150170 | Outer Diameter 3.5 mm | In distribution |
| A14BX030150090 | Catheter Gauge 4.0 Fr | In distribution |
| A14BX030150170 | Length 150.0 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.