Scoreflex PTA Scoring Balloon Catheter
Catheter, Percutaneous, Cutting/Scoring
5manufacturers in China registered for this device type
59catalogue numbers in this listing
3510(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 | OrbusNeich Medical (Shenzhen) Co., Ltd., China |
|---|---|
| FDA product code | LIT |
| Device type | Catheter, Angioplasty, Peripheral, Transluminal |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K182713 |
| Record published | 2019-10-01 |
| Record revised | 2023-06-30 (version 2) |
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, manufacturing date |
| Storage | Special storage condition: Store in dark, cool, dry place. |
| Sizes | Balloon diameter 2 to 6 mm; balloon length 15 to 40 mm; guidewire diameter 0.014 to 0.018 in; catheter length 40 to 150 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AS660-204CU | Balloon Diameter 6.0 mm | In distribution |
| BL635-204CU | Balloon Length 20 mm | In distribution |
| AL635-404NU | Balloon Length 40 mm | In distribution |
| AL620-154CU | Balloon Diameter 2.0 mm | In distribution |
| AL660-404CU | Balloon Diameter 6.0 mm | In distribution |
| AL625-204CU | Balloon Diameter 2.5 mm | In distribution |
| AL625-154NU | Balloon Diameter 2.5 mm | In distribution |
| BM650-204CU | Balloon Length 20 mm | In distribution |
| BL630-154CU | Balloon Length 15 mm | In distribution |
| AL635-154NU | Balloon Length 15 mm | In distribution |
| AL655-204CU | Balloon Diameter 5.5 mm | In distribution |
| BM635-204CU | Balloon Length 20 mm | In distribution |
| BL640-154CU | Balloon Length 15 mm | In distribution |
| AL635-204CU | Balloon Diameter 3.5 mm | In distribution |
| BL650-154CU | Balloon Length 15 mm | In distribution |
| AL645-204CU | Balloon Diameter 4.5 mm | In distribution |
| AL620-204NU | Balloon Diameter 2.0 mm | In distribution |
| AL620-404CU | Balloon Diameter 2.0 mm | In distribution |
| BL660-154CU | Balloon Length 15 mm | In distribution |
| BL620-154CU | Balloon Length 15 mm | In distribution |
| BL650-404CU | Balloon Length 40 mm | In distribution |
| AL640-154CU | Balloon Diameter 4.0 mm | In distribution |
| BM630-204CU | Balloon Length 20 mm | In distribution |
| BL655-204CU | Balloon Length 20 mm | In distribution |
| BS660-204CU | Balloon Length 20 mm | In distribution |
| AS650-204CU | Balloon Diameter 5.0 mm | In distribution |
| AL640-204NU | Balloon Length 20 mm | In distribution |
| BM625-204CU | Balloon Length 20 mm | In distribution |
| AL625-404NU | Balloon Length 40 mm | In distribution |
| BM655-204CU | Balloon Length 20 mm | In distribution |
| BM640-204CU | Balloon Length 20 mm | In distribution |
| AM625-204CU | Balloon Diameter 2.5 mm | In distribution |
| AM645-204CU | Balloon Diameter 4.5 mm | In distribution |
| BL660-404CU | Balloon Length 40 mm | In distribution |
| AS640-204CU | Catheter Length 40 cm | In distribution |
| AL630-404CU | Balloon Diameter 3.0 mm | In distribution |
| BM660-204CU | Balloon Length 20 mm | In distribution |
| BS640-204CU | Balloon Length 20 mm | In distribution |
| BL640-404CU | Balloon Length 40 mm | In distribution |
| BS650-204CU | Balloon Length 20 mm | In distribution |
| AM640-204CU | Balloon Diameter 4.0 mm | In distribution |
| AM630-204CU | Balloon Diameter 3.0 mm | In distribution |
| AL650-154CU | Balloon Diameter 5.0 mm | In distribution |
| AL660-154CU | Balloon Diameter 6.0 mm | In distribution |
| BL620-204CU | Balloon Length 40 mm | In distribution |
| BL630-404CU | Balloon Length 40 mm | In distribution |
| AL650-404CU | Balloon Diameter 5.0 mm | In distribution |
| AM650-204CU | Balloon Diameter 5.0 mm | In distribution |
| AL630-204NU | Balloon Length 20 mm | In distribution |
| BM620-204CU | Balloon Length 20 mm | In distribution |
| AM655-204CU | Balloon Diameter 5.5 mm | In distribution |
| AM620-204CU | Balloon Diameter 2.0 mm | In distribution |
| AM635-204CU | Balloon Diameter 3.5 mm | In distribution |
| AM660-204CU | Balloon Diameter 6.0 mm | In distribution |
| AL640-404CU | Balloon Diameter 4.0 mm | In distribution |
| BL625-204CU | Balloon Length 20 mm | In distribution |
| BL645-204CU | Balloon Length 20 mm | In distribution |
| AL630-154CU | Balloon Diameter 3.0 mm | In distribution |
| BM645-204CU | Balloon Length 20 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 |
|---|---|
| K241025 | 2024-06-11 |
| K202231 | 2020-12-10 |
| K201794 | 2020-07-28 |
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.