Ebony HP PTA OTW 0.035″ Catheter
Ebony HP PTA OTW 0.035" Catheter, 4.00 X 150 MM /Shaft Length 135 CM
5manufacturers in China registered for this device type
164catalogue numbers in this listing
9510(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 | Natec Medical Ltd, MU |
|---|---|
| FDA product code | LIT |
| Device type | Catheter, Angioplasty, Peripheral, Transluminal |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| Establishment | Contract manufacturer, Manufacturer |
| Record published | 2022-08-02 |
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 | Handling environment temperature 15 to 30 °C; Special storage condition: Keep dry and keep away from sunlight |
| Sizes | Balloon diameter 3 to 12 mm; balloon length 20 to 200 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PH075_00-120S | Balloon Diameter 5.00 mm | In distribution |
| PG074_00-150S | Balloon Diameter 4.00 mm | In distribution |
| PG076_00-20S | Balloon Diameter 6.00 mm | In distribution |
| PI074_00-20S | Balloon Diameter 4.00 mm | In distribution |
| PG076_00-100S | Balloon Diameter 6.00 mm | In distribution |
| PI0712_00-80S | Balloon Diameter 12.00 mm | In distribution |
| PI076_00-60S | Balloon Diameter 6.00 mm | In distribution |
| PH074_00-100S | Balloon Diameter 4.00 mm | In distribution |
| PI079_00-80S | Balloon Diameter 9.00 mm | In distribution |
| PG073_00-150S | Balloon Diameter 3.00 mm | In distribution |
| PI078_00-20S | Balloon Diameter 8.00 mm | In distribution |
| PI074_00-80S | Balloon Diameter 4.00 mm | In distribution |
| PG0712_00-20S | Balloon Diameter 12.00 mm | In distribution |
| PH0710_00-60S | Balloon Diameter 10.00 mm | In distribution |
| PG075_00-40S | Balloon Diameter 5.00 mm | In distribution |
| PH078_00-150S | Balloon Diameter 8.00 mm | In distribution |
| PI076_00-120S | Balloon Diameter 6.00 mm | In distribution |
| PG075_00-80S | Balloon Diameter 5.00 mm | In distribution |
| PH076_00-40S | Balloon Diameter 6.00 mm | In distribution |
| PI0712_00-40S | Balloon Diameter 12.00 mm | In distribution |
| PG073_00-200S | Balloon Diameter 3.00 mm | In distribution |
| PH075_00-100S | Balloon Diameter 5.00 mm | In distribution |
| PG077_00-120S | Balloon Diameter 7.00 mm | In distribution |
| PG075_00-120S | Balloon Diameter 5.00 mm | In distribution |
| PH077_00-200S | Balloon Diameter 7.00 mm | In distribution |
| PG077_00-200S | Balloon Diameter 7.00 mm | In distribution |
| PH075_00-200S | Balloon Diameter 5.00 mm | In distribution |
| PG078_00-80S | Balloon Diameter 8.00 mm | In distribution |
| PG076_00-150S | Balloon Diameter 6.00 mm | In distribution |
| PH075_00-20S | Balloon Diameter 5.00 mm | In distribution |
| PI075_00-120S | Balloon Diameter 5.00 mm | In distribution |
| PH076_00-20S | Balloon Diameter 6.00 mm | In distribution |
| PH0712_00-80S | Balloon Diameter 12.00 mm | In distribution |
| PH078_00-60S | Balloon Diameter 8.00 mm | In distribution |
| PG077_00-40S | Balloon Diameter 7.00 mm | In distribution |
| PI0712_00-60S | Balloon Diameter 12.00 mm | In distribution |
| PI0712_00-20S | Balloon Diameter 12.00 mm | In distribution |
| PI073_00-80S | Balloon Diameter 3.00 mm | In distribution |
| PG074_00-120S | Balloon Diameter 4.00 mm | In distribution |
| PH074_00-150S | Balloon Diameter 4.00 mm | In distribution |
| PI078_00-80S | Balloon Diameter 8.00 mm | In distribution |
| PG079_00-60S | Balloon Diameter 9.00 mm | In distribution |
| PG073_00-120S | Balloon Diameter 3.00 mm | In distribution |
| PH078_00-200S | Balloon Diameter 8.00 mm | In distribution |
| PH0712_00-60S | Balloon Diameter 12.00 mm | In distribution |
| PH0710_00-80S | Balloon Diameter 10.00 mm | In distribution |
| PI073_00-40S | Balloon Diameter 3.00 mm | In distribution |
| PI075_00-80S | Balloon Diameter 5.00 mm | In distribution |
| PI078_00-100S | Balloon Diameter 8.00 mm | In distribution |
| PG074_00-80S | Balloon Diameter 4.00 mm | In distribution |
| PH078_00-120S | Balloon Diameter 8.00 mm | In distribution |
| PH077_00-40S | Balloon Diameter 7.00 mm | In distribution |
| PI077_00-60S | Balloon Diameter 7.00 mm | In distribution |
| PH074_00-80S | Balloon Diameter 4.00 mm | In distribution |
| PH078_00-40S | Balloon Diameter 8.00 mm | In distribution |
| PG0712_00-80S | Balloon Diameter 12.00 mm | In distribution |
| PH079_00-80S | Balloon Diameter 9.00 mm | In distribution |
| PG0710_00-80S | Balloon Diameter 10.00 mm | In distribution |
| PI077_00-80S | Balloon Diameter 7.00 mm | In distribution |
| PG075_00-200S | Balloon Diameter 5.00 mm | In distribution |
| PI076_00-20S | Balloon Diameter 6.00 mm | In distribution |
| PG079_00-80S | Balloon Diameter 9.00 mm | In distribution |
| PG079_00-40S | Balloon Diameter 9.00 mm | In distribution |
| PH073_00-100S | Balloon Diameter 3.00 mm | In distribution |
| PI074_00-60S | Balloon Diameter 4.00 mm | In distribution |
| PI074_00-40S | Balloon Diameter 4.00 mm | In distribution |
| PI073_00-60S | Balloon Diameter 3.00 mm | In distribution |
| PH074_00-40S | Balloon Diameter 4.00 mm | In distribution |
| PI074_00-100S | Balloon Diameter 4.00 mm | In distribution |
| PI077_00-100S | Balloon Diameter 7.00 mm | In distribution |
| PG074_00-40S | Balloon Diameter 4.00 mm | In distribution |
| PH078_00-100S | Balloon Diameter 8.00 mm | In distribution |
| PH074_00-60S | Balloon Diameter 4.00 mm | In distribution |
| PG078_00-20S | Balloon Diameter 8.00 mm | In distribution |
| PH073_00-20S | Balloon Diameter 3.00 mm | In distribution |
| PH079_00-60S | Balloon Diameter 9.00 mm | In distribution |
| PG077_00-100S | Balloon Diameter 7.00 mm | In distribution |
| PI079_00-60S | Balloon Diameter 9.00 mm | In distribution |
| PI076_00-100S | Balloon Diameter 6.00 mm | In distribution |
| PG073_00-40S | Balloon Diameter 3.00 mm | In distribution |
| PG0712_00-60S | Balloon Diameter 12.00 mm | In distribution |
| PH078_00-80S | Balloon Diameter 8.00 mm | In distribution |
| PH076_00-120S | Balloon Diameter 6.00 mm | In distribution |
| PG075_00-150S | Balloon Diameter 5.00 mm | In distribution |
| PI076_00-40S | Balloon Diameter 6.00 mm | In distribution |
| PH076_00-100S | Balloon Diameter 6.00 mm | In distribution |
| PG0712_00-40S | Balloon Diameter 12.00 mm | In distribution |
| PH073_00-60S | Balloon Diameter 3.00 mm | In distribution |
| PH074_00-120S | Balloon Diameter 4.00 mm | In distribution |
| PH079_00-20S | Balloon Diameter 9.00 mm | In distribution |
| PG078_00-150S | Balloon Diameter 8.00 mm | In distribution |
| PG0710_00-40S | Balloon Diameter 10.00 mm | In distribution |
| PG076_00-80S | Balloon Diameter 6.00 mm | In distribution |
| PG074_00-20S | Balloon Diameter 4.00 mm | In distribution |
| PH0712_00-40S | Balloon Diameter 12.00 mm | In distribution |
| PH073_00-40S | Balloon Diameter 3.00 mm | In distribution |
| PG076_00-200S | Balloon Diameter 6.00 mm | In distribution |
| PG074_00-200S | Balloon Diameter 4.00 mm | In distribution |
| PI075_00-60S | Balloon Diameter 5.00 mm | In distribution |
| PH076_00-150S | Balloon Diameter 6.00 mm | In distribution |
| PI0710_00-20S | Balloon Diameter 10.00 mm | In distribution |
| PH076_00-60S | Balloon Diameter 6.00 mm | In distribution |
| PH077_00-80S | Balloon Diameter 7.00 mm | In distribution |
| PI075_00-100S | Balloon Diameter 5.00 mm | In distribution |
| PG078_00-100S | Balloon Diameter 8.00 mm | In distribution |
| PI0710_00-40S | Balloon Diameter 10.00 mm | In distribution |
| PI077_00-20S | Balloon Diameter 7.00 mm | In distribution |
| PG078_00-40S | Balloon Diameter 8.00 mm | In distribution |
| PH075_00-40S | Balloon Diameter 5.00 mm | In distribution |
| PI075_00-40S | Balloon Diameter 5.00 mm | In distribution |
| PH076_00-80S | Balloon Diameter 6.00 mm | In distribution |
| PH0710_00-20S | Balloon Diameter 10.00 mm | In distribution |
| PH073_00-150S | Balloon Diameter 3.00 mm | In distribution |
| PH077_00-60S | Balloon Diameter 7.00 mm | In distribution |
| PG078_00-120S | Balloon Diameter 8.00 mm | In distribution |
| PI078_00-40S | Balloon Diameter 8.00 mm | In distribution |
| PG075_00-20S | Balloon Diameter 5.00 mm | In distribution |
| PG077_00-80S | Balloon Diameter 7.00 mm | In distribution |
| PG079_00-20S | Balloon Diameter 9.00 mm | In distribution |
| PG074_00-60S | Balloon Diameter 4.00 mm | In distribution |
| PG0710_00-20S | Balloon Diameter 10.00 mm | In distribution |
| PG074_00-100S | Balloon Diameter 4.00 mm | In distribution |
| PH077_00-150S | Balloon Diameter 7.00 mm | In distribution |
| PG075_00-100S | Balloon Diameter 5.00 mm | In distribution |
| PI079_00-40S | Balloon Diameter 9.00 mm | In distribution |
| PH075_00-60S | Balloon Diameter 5.00 mm | In distribution |
| PG073_00-80S | Balloon Diameter 3.00 mm | In distribution |
| PH077_00-20S | Balloon Diameter 7.00 mm | In distribution |
| PI0710_00-60S | Balloon Diameter 10.00 mm | In distribution |
| PG073_00-100S | Balloon Diameter 3.00 mm | In distribution |
| PG077_00-150S | Balloon Diameter 7.00 mm | In distribution |
| PI076_00-80S | Balloon Diameter 6.00 mm | In distribution |
| PG077_00-60S | Balloon Diameter 7.00 mm | In distribution |
| PH073_00-120S | Balloon Diameter 3.00 mm | In distribution |
| PI073_00-100S | Balloon Diameter 3.00 mm | In distribution |
| PI078_00-60S | Balloon Diameter 8.00 mm | In distribution |
| PI077_00-40S | Balloon Diameter 7.00 mm | In distribution |
| PH075_00-150S | Balloon Diameter 5.00 mm | In distribution |
| PH078_00-20S | Balloon Diameter 8.00 mm | In distribution |
| PG073_00-60S | Balloon Diameter 3.00 mm | In distribution |
| PH076_00-200S | Balloon Diameter 6.00 mm | In distribution |
| PG073_00-20S | Balloon Diameter 3.00 mm | In distribution |
| PH0710_00-40S | Balloon Diameter 10.00 mm | In distribution |
| PI0710_00-80S | Balloon Diameter 10.00 mm | In distribution |
| PH074_00-200S | Balloon Diameter 4.00 mm | In distribution |
| PI073_00-20S | Balloon Diameter 3.00 mm | In distribution |
| PH0712_00-20S | Balloon Diameter 12.00 mm | In distribution |
| PG0710_00-60S | Balloon Diameter 10.00 mm | In distribution |
| PG076_00-40S | Balloon Diameter 6.00 mm | In distribution |
| PG076_00-60S | Balloon Diameter 6.00 mm | In distribution |
| PH077_00-120S | Balloon Diameter 7.00 mm | In distribution |
| PG078_00-200S | Balloon Diameter 8.00 mm | In distribution |
| PH074_00-20S | Balloon Diameter 4.00 mm | In distribution |
| PH077_00-100S | Balloon Diameter 7.00 mm | In distribution |
| PG077_00-20S | Balloon Diameter 7.00 mm | In distribution |
| PG078_00-60S | Balloon Diameter 8.00 mm | In distribution |
| PH073_00-200S | Balloon Diameter 3.00 mm | In distribution |
| PH075_00-80S | Balloon Diameter 5.00 mm | In distribution |
| PH079_00-40S | Balloon Diameter 9.00 mm | In distribution |
| PG075_00-60S | Balloon Diameter 5.00 mm | In distribution |
| PI075_00-20S | Balloon Diameter 5.00 mm | In distribution |
| PG076_00-120S | Balloon Diameter 6.00 mm | In distribution |
| PH073_00-80S | Balloon Diameter 3.00 mm | In distribution |
| PI079_00-20S | Balloon Diameter 9.00 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251915 | 2025-12-18 |
| K241040 | 2024-12-18 |
| K220410 | 2022-06-29 |
| K152230 | 2015-09-03 |
| K143041 | 2015-06-04 |
| K143036 | 2015-03-30 |
| K142459 | 2015-02-03 |
| K112513 | 2011-12-09 |
| K103354 | 2011-02-23 |
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.