Advocate
Advocate 0.035” PTA Catheter (10.0mm x 100mm x 1300mm)
5manufacturers in China registered for this device type
441catalogue numbers in this listing
4510(k) clearances naming this product 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 | Arravasc, Ltd., Ireland |
|---|---|
| FDA product code | LIT |
| Device type | Catheter, Angioplasty, Peripheral, Transluminal |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| 510(k) | K161427 |
| Record published | 2016-09-20 |
| Record revised | 2019-08-09 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store in a dark, dry, cool place. Avoid extended exposure to light, organic solvents, ionizing radiation or ultraviolet |
| Sizes | Outer diameter 1.25 to 250 mm; length 2 to 300 mm; pore size 1.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A35030040075 | Length 40 mm | In distribution |
| A14035020130 | Outer Diameter 3.5 mm | In distribution |
| A14040100090 | Outer Diameter 4.0 mm | In distribution |
| A14020200150 | Outer Diameter 2.0 mm | In distribution |
| A18060150150 | Length 150 mm | In distribution |
| A14015080150 | Outer Diameter 1.5 mm | In distribution |
| A14020060130 | Outer Diameter 2.0 mm | In distribution |
| A18060080090 | Length 80 mm | In distribution |
| A14015015090 | Outer Diameter 1.5 mm | In distribution |
| A35070200075 | Length 200 mm | In distribution |
| A18060100150 | Length 100 mm | In distribution |
| A14035040150 | Outer Diameter 3.5 mm | In distribution |
| A18030250150 | Length 250 mm | In distribution |
| A18030300150 | Length 300 mm | In distribution |
| A14035200130 | Outer Diameter 3.5 mm | In distribution |
| A14020100130 | Outer Diameter 2.0 mm | In distribution |
| A18030100130 | Length 100 mm | In distribution |
| A18060100090 | Length 100 mm | In distribution |
| A18060040045 | Length 40 mm | In distribution |
| A35100080075 | Length 80 mm | In distribution |
| A14035020090 | Outer Diameter 3.5 mm | In distribution |
| A18050250150 | Length 250 mm | In distribution |
| A14035040090 | Length 40 mm | In distribution |
| A35040080075 | Length 80 mm | In distribution |
| A35050040075 | Length 40 mm | In distribution |
| A14030150130 | Outer Diameter 3.0 mm | In distribution |
| A18035040090 | Length 40 mm | In distribution |
| A18025300150 | Length 300 mm | In distribution |
| A35040060075 | Length 60 mm | In distribution |
| A35060060075 | Length 60 mm | In distribution |
| A14030015150 | Outer Diameter 3.0 mm | In distribution |
| A35070200130 | Length 200 mm | In distribution |
| A35100020075 | Length 20 mm | In distribution |
| A18020250130 | Length 250 mm | In distribution |
| A14030060130 | Outer Diameter 3.0 mm | In distribution |
| A35060080130 | Length 80 mm | In distribution |
| A18025100150 | Length 100 mm | In distribution |
| A14015080130 | Outer Diameter 1.5 mm | In distribution |
| A18050040090 | Length 40 mm | In distribution |
| A14035300130 | Outer Diameter 3.5 mm | In distribution |
| A18040250090 | Length 250 mm | In distribution |
| A14035200150 | Outer Diameter 3.5 mm | In distribution |
| A14025100150 | Outer Diameter 2.5 mm | In distribution |
| A35060100130 | Length 100 mm | In distribution |
| A18035100130 | Length 100 mm | In distribution |
| A14020250150 | Outer Diameter 2.0 mm | In distribution |
| A18060200150 | Length 200 mm | In distribution |
| A18035100090 | Length 100 mm | In distribution |
| A35070150075 | Length 150 mm | In distribution |
| A35030100075 | Length 100 mm | In distribution |
| A18070150130 | Length 150 mm | In distribution |
| A35070020075 | Length 20 mm | In distribution |
| A35090060130 | Length 60 mm | In distribution |
| A14035080090 | Outer Diameter 3.5 mm | In distribution |
| A14035040130 | Outer Diameter 3.5 mm | In distribution |
| A18050250130 | Length 250 mm | In distribution |
| A14030250090 | Length 250 mm | In distribution |
| A18035100150 | Length 100 mm | In distribution |
| A18040080130 | Length 80 mm | In distribution |
| A18030040130 | Length 40 mm | In distribution |
| A14020020130 | Outer Diameter 2.0 mm | In distribution |
| A14030250150 | Outer Diameter 3.0 mm | In distribution |
| A18070060045 | Length 60 mm | In distribution |
| A14015040150 | Outer Diameter 1.5 mm | In distribution |
| A14040060130 | Outer Diameter 4.0 mm | In distribution |
| A35050150075 | Length 150 mm | In distribution |
| A18040150130 | Length 150 mm | In distribution |
| A35090020130 | Length 20 mm | In distribution |
| A18060060090 | Length 60 mm | In distribution |
| A18060040090 | Length 40 mm | In distribution |
| A35040100130 | Length 100 mm | In distribution |
| A14025250130 | Outer Diameter 2.5 mm | In distribution |
| A14035200090 | Outer Diameter 3.5 mm | In distribution |
| A18050250090 | Length 250 mm | In distribution |
| A14040200130 | Outer Diameter 4.0 mm | In distribution |
| A18080040090 | Length 40 mm | In distribution |
| A14020040130 | Outer Diameter 2.0 mm | In distribution |
| A18025250150 | Outer Diameter 250 mm | In distribution |
| A35030200130 | Length 200 mm | In distribution |
| A18050040045 | Outer Diameter 5.0 mm | In distribution |
| A14030040090 | Outer Diameter 3.0 mm | In distribution |
| A18040060045 | Length 60 mm | In distribution |
| A35100100075 | Length 100 mm | In distribution |
| A14030015090 | Outer Diameter 3.0 mm | In distribution |
| A14020100150 | Outer Diameter 2.0 mm | In distribution |
| A14030020150 | Outer Diameter 3.0 mm | In distribution |
| A35080040075 | Length 40 mm | In distribution |
| A14020100090 | Outer Diameter 2.0 mm | In distribution |
| A14020250130 | Outer Diameter 2.0 mm | In distribution |
| A35030100130 | Length 100 mm | In distribution |
| A14040015150 | Outer Diameter 4.0 mm | In distribution |
| A14030100090 | Outer Diameter 3.0 mm | In distribution |
| A14020015150 | Outer Diameter 2.0 mm | In distribution |
| A18040040090 | Length 40 mm | In distribution |
| A18040150090 | Length 150 mm | In distribution |
| A35060100075 | Length 100 mm | In distribution |
| A18035150090 | Length 150 mm | In distribution |
| A35070040130 | Outer Diameter 7.0 mm | In distribution |
| A18040060150 | Outer Diameter 4.0 mm | In distribution |
| A14025150130 | Outer Diameter 2.5 mm | In distribution |
| A14015150150 | Outer Diameter 1.5 mm | In distribution |
| A18060200130 | Length 200 mm | In distribution |
| A18060150130 | Length 150 mm | In distribution |
| A35090100130 | Length 100 mm | In distribution |
| A14030150150 | Outer Diameter 3.0 mm | In distribution |
| A35030060075 | Length 60 mm | In distribution |
| A14035100130 | Outer Diameter 3.5 mm | In distribution |
| A35120040130 | Length 40 mm | In distribution |
| A14012020150 | Outer Diameter 1.25 mm | In distribution |
| A14025060150 | Outer Diameter 2.5 mm | In distribution |
| A18035200130 | Length 200 mm | In distribution |
| A18030080090 | Length 80 mm | In distribution |
| A18070040045 | Length 40 mm | In distribution |
| A35090080130 | Length 80 mm | In distribution |
| A35060060130 | Length 60 mm | In distribution |
| A18080100090 | Length 100 mm | In distribution |
| A14030080130 | Outer Diameter 3.0 mm | In distribution |
| A18035250150 | Length 250 mm | In distribution |
| A18020060130 | Length 60 mm | In distribution |
| A14020015130 | Outer Diameter 2.0 mm | In distribution |
| A14040040150 | Outer Diameter 4.0 mm | In distribution |
| A14015150130 | Outer Diameter 1.5 mm | In distribution |
| A14035020150 | Outer Diameter 3.5 mm | In distribution |
| A14035060130 | Outer Diameter 3.5 mm | In distribution |
| A18070080090 | Length 80 mm | In distribution |
| A35060080075 | Length 80 mm | In distribution |
| A18030100150 | Length 100 mm | In distribution |
| A14015100090 | Outer Diameter 1.5 mm | In distribution |
| A35040060130 | Length 60 mm | In distribution |
| A14025040130 | Outer Diameter 2.5 mm | In distribution |
| A14025150090 | Outer Diameter 2.5 mm | In distribution |
| A18060250150 | Length 250 mm | In distribution |
| A14015100150 | Outer Diameter 1.5 mm | In distribution |
| A14020040090 | Outer Diameter 2.0 mm | In distribution |
| A18025300130 | Length 300 mm | In distribution |
| A35030040130 | Length 40 mm | In distribution |
| A35090020075 | Length 20 mm | In distribution |
| A18030060090 | Length 60 mm | In distribution |
| A14015020090 | Outer Diameter 1.5 mm | In distribution |
| A35050020130 | Length 20 mm | In distribution |
| A14025150150 | Outer Diameter 2.5 mm | In distribution |
| A18040080090 | Length 80 mm | In distribution |
| A18070150150 | Length 150 mm | In distribution |
| A18035060150 | Length 60 mm | In distribution |
| A18030100090 | Length 100 mm | In distribution |
| A18030200130 | Length 200 mm | In distribution |
| A14020300130 | Outer Diameter 2.0 mm | In distribution |
| A35080080130 | Length 80 mm | In distribution |
| A35100020130 | Length 20 mm | In distribution |
| A18060040150 | Length 40 mm | In distribution |
| A18025080130 | Length 80 mm | In distribution |
| A14040100130 | Outer Diameter 4.0 mm | In distribution |
| A14035080150 | Outer Diameter 3.5 mm | In distribution |
| A18040250130 | Length 250 mm | In distribution |
| A14030060150 | Outer Diameter 3.0 mm | In distribution |
| A18035200090 | Length 200 mm | In distribution |
| A35080020075 | Length 20 mm | In distribution |
| A14020080090 | Outer Diameter 2.0 mm | In distribution |
| A14020150130 | Outer Diameter 2.0 mm | In distribution |
| A14040150090 | Outer Diameter 4.0 mm | In distribution |
| A18035080130 | Length 80 mm | In distribution |
| A14030100130 | Outer Diameter 3.0 mm | In distribution |
| A35100040075 | Length 40 mm | In distribution |
| A14030015130 | Outer Diameter 3.0 mm | In distribution |
| A35050040130 | Length 40 mm | In distribution |
| A14040020130 | Outer Diameter 4.0 mm | In distribution |
| A18035040150 | Outer Diameter 3.5 mm | In distribution |
| A14040040090 | Outer Diameter 4.0 mm | In distribution |
| A18040100090 | Length 100 mm | In distribution |
| A14030060090 | Outer Diameter 3.0 mm | In distribution |
| A18040250150 | Length 250 mm | In distribution |
| A18050040150 | Length 40 mm | In distribution |
| A35040020075 | Length 20 mm | In distribution |
| A14025015150 | Outer Diameter 2.5 mm | In distribution |
| A18025150130 | Length 150 mm | In distribution |
| A14040060150 | Outer Diameter 4.0 mm | In distribution |
| A18020150130 | Length 150 mm | In distribution |
| A35070040075 | Length 40 mm | In distribution |
| A35060200075 | Length 200 mm | In distribution |
| A14035100090 | Outer Diameter 3.5 mm | In distribution |
| A14025040090 | Outer Diameter 2.5 mm | In distribution |
| A35030080130 | Length 80 mm | In distribution |
| A14030200150 | Outer Diameter 3.0 mm | In distribution |
| A14020060090 | Outer Diameter 2.0 mm | In distribution |
| A14015040130 | Outer Diameter 1.5 mm | In distribution |
| A35060200130 | Outer Diameter 6.0 mm | In distribution |
| A14015060150 | Outer Diameter 1.5 mm | In distribution |
| A14020250090 | Outer Diameter 2.0 mm | In distribution |
| A18040100130 | Length 100 mm | In distribution |
| A18020100150 | Length 100 mm | In distribution |
| A14035080130 | Outer Diameter 3.5 mm | In distribution |
| A14015020130 | Outer Diameter 1.5 mm | In distribution |
| A18090060090 | Length 60 mm | In distribution |
| A18070080130 | Length 80 mm | In distribution |
| A35060040075 | Length 40 mm | In distribution |
| A18035150130 | Length 150 mm | In distribution |
| A18030060130 | Length 60 mm | In distribution |
| A35070150130 | Length 150 mm | In distribution |
| A14025200130 | Outer Diameter 2.5 mm | In distribution |
| A18020060150 | Length 60 mm | In distribution |
| A18070100090 | Length 100 mm | In distribution |
| A14025040150 | Outer Diameter 2.5 mm | In distribution |
| A14025015130 | Outer Diameter 2.5 mm | In distribution |
| A18020020150 | Length 20 mm | In distribution |
| A35050100130 | Length 100 mm | In distribution |
| A18030060150 | Length 60 mm | In distribution |
| A35080100130 | Outer Diameter 100 mm | In distribution |
| A35120020075 | Length 20 mm | In distribution |
| A18040040045 | Outer Diameter 4.0 mm | In distribution |
| A14025015090 | Outer Diameter 2.5 mm | In distribution |
| A14020020150 | Outer Diameter 2.0 mm | In distribution |
| A18025250130 | Length 250 mm | In distribution |
| A14040060090 | Outer Diameter 4.0 mm | In distribution |
| A35040150130 | Length 150 mm | In distribution |
| A14025020090 | Outer Diameter 2.5 mm | In distribution |
| A18020200150 | Length 200 mm | In distribution |
| A35100080130 | Length 80 mm | In distribution |
| A14020200130 | Outer Diameter 2.0 mm | In distribution |
| A35050080075 | Length 80 mm | In distribution |
| A14030020090 | Outer Diameter 3.0 mm | In distribution |
| A14030100150 | Outer Diameter 3.0 mm | In distribution |
| A14015015130 | Outer Diameter 1.5 mm | In distribution |
| A35080060130 | Length 60 mm | In distribution |
| A14025250090 | Outer Diameter 2.5 mm | In distribution |
| A18020300130 | Length 300 mm | In distribution |
| A18050060045 | Length 60 mm | In distribution |
| A18025060090 | Length 60 mm | In distribution |
| A18090040090 | Length 40 mm | In distribution |
| A18070100130 | Length 100 mm | In distribution |
| A14025080090 | Outer Diameter 2.5 mm | In distribution |
| A14035060150 | Outer Diameter 3.5 mm | In distribution |
| A18030080130 | Length 80 mm | In distribution |
| A18050080090 | Length 80 mm | In distribution |
| A18050100150 | Length 100 mm | In distribution |
| A14015040090 | Outer Diameter 1.5 mm | In distribution |
| A14030150090 | Outer Diameter 3.0 mm | In distribution |
| A35080060075 | Length 60 mm | In distribution |
| A14040015090 | Outer Diameter 4.0 mm | In distribution |
| A18060200090 | Length 200 mm | In distribution |
| A35040200130 | Length 200 mm | In distribution |
| A14040020150 | Outer Diameter 4.0 mm | In distribution |
| A14030300130 | Outer Diameter 3.0 mm | In distribution |
| A18020080130 | Length 80 mm | In distribution |
| A18070150090 | Length 150 mm | In distribution |
| A14025300150 | Outer Diameter 2.5 mm | In distribution |
| A14035150090 | Outer Diameter 3.5 mm | In distribution |
| A14025250150 | Outer Diameter 2.5 mm | In distribution |
| A18030300130 | Length 300 mm | In distribution |
| A35030080075 | Length 80 mm | In distribution |
| A35060020130 | Length 20 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 |
| 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 |
| 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 |
|---|---|
| K172033 | 2017-08-31 |
| K162316 | 2016-11-22 |
| K161427 | 2016-07-30 |
| K151153 | 2015-08-20 |
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.