Ultrascore
ULTRASCORE™ Focused Force PTA Balloon 3.5mm x 120mm, 150cm catheter
3manufacturers in China registered for this device type
103catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Bard Peripheral Vascular, Inc., United States |
|---|---|
| FDA product code | PNO |
| Device type | Catheter, Percutaneous, Cutting/Scoring |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2018-03-20 |
| Record revised | 2019-08-09 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| US35130412 | Shaft Length, 130 Centimeter | In distribution |
| US14150520 | Balloon Diameter, 5 Millimeter | In distribution |
| US14150420 | Balloon Length, 200 Millimeter | In distribution |
| US14150610 | Shaft Length, 150 Centimeter | In distribution |
| US1415048 | Balloon Diameter, 4 Millimeter | In distribution |
| US14150510 | Balloon Diameter, 5 Millimeter | In distribution |
| US141503H8 | Shaft Length, 150 Centimeter | In distribution |
| US14150620 | Balloon Length, 200 Millimeter | In distribution |
| US35130510 | Shaft Length, 130 Centimeter | In distribution |
| US35130420 | Shaft Length, 130 Centimeter | In distribution |
| US14150210 | Balloon Diameter, 2 Millimeter | In distribution |
| US14150630 | Balloon Length, 300 Millimeter | In distribution |
| US1415024 | Balloon Diameter, 2 Millimeter | In distribution |
| US141503H12 | Balloon Diameter, 3.5 Millimeter | In distribution |
| US35130410 | Shaft Length, 130 Centimeter | In distribution |
| US35130715 | Balloon Diameter, 7 Millimeter | In distribution |
| US141502H20 | Balloon Length, 200 Millimeter | In distribution |
| US35130415 | Balloon Diameter, 4 Millimeter | In distribution |
| US14150412 | Balloon Length, 120 Millimeter | In distribution |
| US35130810 | Balloon Length, 100 Millimeter | In distribution |
| US1415052 | Balloon Length, 20 Millimeter | In distribution |
| US14150710 | Balloon Diameter, 7 Millimeter | In distribution |
| US14150712 | Shaft Length, 150 Centimeter | In distribution |
| US14150612 | Balloon Diameter, 6 Millimeter | In distribution |
| US3513064 | Balloon Diameter, 6 Millimeter | In distribution |
| US35130815 | Shaft Length, 130 Centimeter | In distribution |
| US35130630 | Balloon Diameter, 6 Millimeter | In distribution |
| US141502H15 | Balloon Diameter, 2.5 Millimeter | In distribution |
| US14150530 | Balloon Diameter, 5 Millimeter | In distribution |
| US14150715 | Balloon Diameter, 7 Millimeter | In distribution |
| US14150215 | Balloon Diameter, 2 Millimeter | In distribution |
| US14150515 | Shaft Length, 150 Centimeter | In distribution |
| US141502H30 | Balloon Length, 300 Millimeter | In distribution |
| US141503H20 | Shaft Length, 150 Centimeter | In distribution |
| US3513058 | Balloon Diameter, 5 Millimeter | In distribution |
| US3513078 | Balloon Length, 80 Millimeter | In distribution |
| US141503H30 | Shaft Length, 150 Centimeter | In distribution |
| US3513088 | Balloon Diameter, 8 Millimeter | In distribution |
| US1415042 | Balloon Diameter, 4 Millimeter | In distribution |
| US141503H10 | Balloon Diameter, 3.5 Millimeter | In distribution |
| US14150410 | Balloon Length, 100 Millimeter | In distribution |
| US1415054 | Shaft Length, 150 Centimeter | In distribution |
| US14150230 | Balloon Length, 300 Millimeter | In distribution |
| US1415064 | Balloon Diameter, 6 Millimeter | In distribution |
| US141503H15 | Balloon Length, 150 Millimeter | In distribution |
| US1415078 | Shaft Length, 150 Centimeter | In distribution |
| US14150512 | Shaft Length, 150 Centimeter | In distribution |
| US14150212 | Balloon Length, 120 Millimeter | In distribution |
| US35130620 | Shaft Length, 130 Centimeter | In distribution |
| US14150312 | Shaft Length, 150 Centimeter | In distribution |
| US141502H10 | Balloon Length, 100 Millimeter | In distribution |
| US35130610 | Balloon Length, 100 Millimeter | In distribution |
| US14150220 | Balloon Diameter, 2 Millimeter | In distribution |
| US3513082 | Balloon Length, 20 Millimeter | In distribution |
| US14150430 | Balloon Length, 300 Millimeter | In distribution |
| US1415032 | Balloon Diameter, 3 Millimeter | In distribution |
| US14150720 | Shaft Length, 150 Centimeter | In distribution |
| US35130512 | Balloon Length, 120 Millimeter | In distribution |
| US3513074 | Balloon Length, 40 Millimeter | In distribution |
| US3513052 | Balloon Diameter, 5 Millimeter | In distribution |
| US35130615 | Shaft Length, 130 Centimeter | In distribution |
| US1415074 | Shaft Length, 150 Centimeter | In distribution |
| US141502H12 | Balloon Length, 120 Millimeter | In distribution |
| US14150615 | Shaft Length, 150 Centimeter | In distribution |
| US14150310 | Balloon Diameter, 3 Millimeter | In distribution |
| US1415044 | Balloon Diameter, 4 Millimeter | In distribution |
| US35130712 | Balloon Diameter, 7 Millimeter | In distribution |
| US35130515 | Shaft Length, 130 Centimeter | In distribution |
| US1415038 | Shaft Length, 150 Centimeter | In distribution |
| US3513042 | Balloon Diameter, 4 Millimeter | In distribution |
| US3513054 | Shaft Length, 130 Centimeter | In distribution |
| US3513048 | Balloon Length, 80 Millimeter | In distribution |
| US1415072 | Shaft Length, 150 Centimeter | In distribution |
| US35130530 | Balloon Diameter, 5 Millimeter | In distribution |
| US14150730 | Shaft Length, 150 Centimeter | In distribution |
| US1415022 | Balloon Diameter, 2 Millimeter | In distribution |
| US14150330 | Balloon Length, 300 Millimeter | In distribution |
| US14150320 | Shaft Length, 150 Centimeter | In distribution |
| US141503H4 | Balloon Diameter, 3.5 Millimeter | In distribution |
| US35130430 | Balloon Length, 300 Millimeter | In distribution |
| US1415028 | Shaft Length, 150 Centimeter | In distribution |
| US35130812 | Balloon Length, 120 Millimeter | In distribution |
| US35130612 | Shaft Length, 130 Centimeter | In distribution |
| US141502H8 | Balloon Diameter, 2.5 Millimeter | In distribution |
| US35130730 | Shaft Length, 130 Centimeter | In distribution |
| US141503H2 | Shaft Length, 150 Centimeter | In distribution |
| US3513068 | Balloon Length, 80 Millimeter | In distribution |
| US141502H2 | Balloon Diameter, 2.5 Millimeter | In distribution |
| US14150315 | Shaft Length, 150 Centimeter | In distribution |
| US3513084 | Shaft Length, 130 Centimeter | In distribution |
| US3513072 | Shaft Length, 130 Centimeter | In distribution |
| US35130720 | Balloon Length, 200 Millimeter | In distribution |
| US1415058 | Shaft Length, 150 Centimeter | In distribution |
| US1415034 | Shaft Length, 150 Centimeter | In distribution |
| US141502H4 | Balloon Diameter, 2.5 Millimeter | In distribution |
| US35130710 | Balloon Diameter, 7 Millimeter | In distribution |
| US3513062 | Balloon Diameter, 6 Millimeter | In distribution |
| US3513044 | Balloon Diameter, 4 Millimeter | In distribution |
| US14150415 | Balloon Diameter, 4 Millimeter | In distribution |
| US35130520 | Balloon Length, 200 Millimeter | In distribution |
| US1415062 | Shaft Length, 150 Centimeter | In distribution |
| US35130820 | Balloon Diameter, 8 Millimeter | In distribution |
| US1415068 | Balloon Length, 80 Millimeter | 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 |
| Scoreflex PTA Scoring Balloon Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | 58 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K260012 | 2026-02-04 |
| K163420 | 2017-06-14 |
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.