Scoreflex PTA Scoring Balloon Catheter
Catheter, Percutaneous, Cutting/Scoring
3manufacturers in China registered for this device type
58catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| OrbusNeich Medical (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Complaint-file establishment | 5 |
| Brosmed Medical Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| DK Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
Record
| Listed by | OrbusNeich Medical (Shenzhen) Co., Ltd., China |
|---|---|
| FDA product code | PNO |
| Device type | Catheter, Percutaneous, Cutting/Scoring |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K182713 |
| Record published | 2019-10-01 |
| Record revised | 2023-06-29 (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 | Catheter length 40 to 150 cm; guidewire diameter 0.014 to 0.018 in; balloon length 15 to 40 mm; balloon diameter 2 to 6 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AS640-404CU | Catheter Length 40 cm | In distribution |
| AL630-154NU | Balloon Diameter 3.0 mm | In distribution |
| AL625-204NU | Catheter Length 150 cm | In distribution |
| BM660-404CU | Balloon Diameter 6.0 mm | In distribution |
| BL630-204CU | Balloon Diameter 3.0 mm | In distribution |
| BL645-154CU | Balloon Diameter 4.5 mm | In distribution |
| BL650-204CU | Balloon Diameter 5.0 mm | In distribution |
| BL635-404CU | Balloon Diameter 3.5 mm | In distribution |
| AL645-154CU | Catheter Length 150 cm | In distribution |
| BM640-404CU | Balloon Diameter 4.0 mm | In distribution |
| BM635-404CU | Balloon Diameter 3.5 mm | In distribution |
| AM660-404CU | Catheter Length 90 cm | In distribution |
| AL625-404CU | Catheter Length 150 cm | In distribution |
| BL620-204CU | Balloon Diameter 2.0 mm | In distribution |
| AL630-404NU | Balloon Diameter 3.0 mm | In distribution |
| BS650-404CU | Balloon Diameter 5.0 mm | In distribution |
| AL630-204CU | Catheter Length 150 cm | In distribution |
| BM655-404CU | Balloon Diameter 5.5 mm | In distribution |
| AM640-404CU | Catheter Length 90 cm | In distribution |
| BM645-404CU | Balloon Diameter 4.5 mm | In distribution |
| AL620-154NU | Catheter Length 150 cm | In distribution |
| AL650-204CU | Catheter Length 150 cm | In distribution |
| AL640-204CU | Catheter Length 150 cm | In distribution |
| AM655-404CU | Catheter Length 90 cm | In distribution |
| BM630-404CU | Balloon Diameter 3.0 mm | In distribution |
| AM645-404CU | Catheter Length 90 cm | In distribution |
| AL635-204NU | Balloon Diameter 3.5 mm | In distribution |
| AL625-154CU | Catheter Length 150 cm | In distribution |
| AM635-404CU | Catheter Length 90 cm | In distribution |
| AL660-204CU | Catheter Length 150 cm | In distribution |
| BS660-404CU | Balloon Diameter 6.0 mm | In distribution |
| AL640-154NU | Balloon Diameter 4.0 mm | In distribution |
| AS650-404CU | Catheter Length 40 cm | In distribution |
| AL655-154CU | Catheter Length 150 cm | In distribution |
| BL625-154CU | Balloon Diameter 2.5 mm | In distribution |
| BL660-204CU | Balloon Diameter 6.0 mm | In distribution |
| BL655-404CU | Balloon Diameter 5.5 mm | In distribution |
| BM625-404CU | Balloon Diameter 2.5 mm | In distribution |
| AL620-204CU | Catheter Length 150 cm | In distribution |
| AL635-404CU | Catheter Length 150 cm | In distribution |
| AM650-404CU | Catheter Length 90 cm | In distribution |
| AL645-404CU | Catheter Length 150 cm | In distribution |
| BL640-204CU | Balloon Diameter 4.0 mm | In distribution |
| AL640-404NU | Balloon Diameter 4.0 mm | In distribution |
| BS640-404CU | Balloon Diameter 4.0 mm | In distribution |
| BL635-154CU | Balloon Diameter 3.5 mm | In distribution |
| BL645-404CU | Balloon Diameter 4.5 mm | In distribution |
| AS660-404CU | Catheter Length 40 cm | In distribution |
| BL625-404CU | Balloon Diameter 2.5 mm | In distribution |
| AL620-404NU | Catheter Length 150 cm | In distribution |
| AL635-154CU | Catheter Length 150 cm | In distribution |
| BM650-404CU | Balloon Diameter 5.0 mm | In distribution |
| AM620-404CU | Catheter Length 90 cm | In distribution |
| AM625-404CU | Catheter Length 90 cm | In distribution |
| BL655-154CU | Balloon Diameter 5.5 mm | In distribution |
| BM620-404CU | Balloon Diameter 2.0 mm | In distribution |
| AL655-404CU | Catheter Length 150 cm | In distribution |
| AM630-404CU | Catheter Length 90 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tri-Wedge PTA Scoring Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 168 |
| PTA Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | 120 |
| VascuTrak® | Bard Peripheral Vascular, Inc. | 109 |
| Ultrascore | Bard Peripheral Vascular, Inc. | 103 |
| AngioSculpt® | Spectranetics Corp. | 51 |
| Aperta NSE™ PTA Balloon Dilatation Catheter | Goodman Co., Ltd. | 38 |
| AngioSculpt OTW PTA Scoring Balloon Catheter | The Spectranetics Corp. | 25 |
| Serranator | Cagent Vascular | 18 |
| AngioSculpt OTW PTA Scoring Balloon Catheter with HydroCross Coating | The Spectranetics Corp. | 13 |
| Advance Enforcer | Cook Incorporated | 12 |
| 2cm Peripheral Cutting Balloon® | Boston Scientific Corporation | 12 |
| Peripheral Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | 11 |
Showing 12 of 16. All products under Catheter, Percutaneous, Cutting/Scoring
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.