AngioSculpt®
AngioSculpt PTA Scoring Balloon Catheter with HydroCross Coating
3manufacturers in China registered for this device type
51catalogue 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 | Spectranetics Corp., 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 | 2016-09-23 |
| Record revised | 2023-08-08 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature up to 140 °F |
| Sizes | Outer diameter 2 to 6 mm; length 10 to 100 mm; balloon length 100 mm |
| Distribution end date | 2020-02-20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2092-6020-A | Length 20 mm | In distribution |
| 2155-2040-A | Length 40 mm | In distribution |
| 2216-30100-A | Length 100 mm | In distribution |
| 2092-6040-A | Length 40 mm | In distribution |
| 2215-35100 | Length 100 mm | In distribution |
| 2076‐5020-A | Length 20 mm | In distribution |
| 2155-3040-A | Length 40 mm | In distribution |
| 2076‐4040-A | Length 40 mm | In distribution |
| 2155-2540-A | Length 40 mm | In distribution |
| 2105-6040-A | Length 40 mm | In distribution |
| 2105-6020-A | Length 20 mm | In distribution |
| 2076‐5040-A | Length 40 mm | In distribution |
| 2092-5040-A | Length 40 mm | In distribution |
| 2076‐6040-A | Length 40 mm | In distribution |
| 2216-20100-A | Length 100 mm | In distribution |
| 2092-4040-A | Length 40 mm | In distribution |
| 2155-3540-A | Length 40 mm | In distribution |
| 2215-30100 | Length 100 mm | In distribution |
| 2076‐4020-A | Length 20 mm | In distribution |
| 2039-3020-A | Length 20 mm | In distribution |
| 2216-35100-A | Length 100 mm | In distribution |
| 2215-20100 | Length 100 mm | In distribution |
| 2076‐6020-A | Length 20 mm | In distribution |
| 2216-25100-A | Length 100 mm | In distribution |
| 2039-3520-A | Length 20 mm | In distribution |
| 2215-25100 | Length 100 mm | In distribution |
| 2215-25100-A | Length 100 mm | Withdrawn |
| 2237-40100 | Length 100 mm | Withdrawn |
| 2290-50100 | Length 100 mm | Withdrawn |
| 2039-2010-A | Length 10 mm | Withdrawn |
| 2216-20100 | Balloon Length 100 mm | Withdrawn |
| 2290-60100-A | Length 100 mm | Withdrawn |
| 2215-35100-A | Length 100 mm | Withdrawn |
| 2039-2010 | Length 10 mm | Withdrawn |
| 2237-40100-A | Length 100 mm | Withdrawn |
| 2216-35100 | Length 100 mm | Withdrawn |
| 2237-50100-A | Length 100 mm | Withdrawn |
| 2039-2020 | Length 20 mm | Withdrawn |
| 2237-60100-A | Length 100 mm | Withdrawn |
| 2290-50100-A | Length 100 mm | Withdrawn |
| 2290-40100 | Length 100 mm | Withdrawn |
| 2216-30100 | Length 100 mm | Withdrawn |
| 2216-25100 | Length 100 mm | Withdrawn |
| 2237-60100 | Length 100 mm | Withdrawn |
| 2290-60100 | Length 100 mm | Withdrawn |
| 2215-20100-A | Balloon Length 100 mm | Withdrawn |
| 2215-30100-A | Length 100 mm | Withdrawn |
| 2290-40100-A | Length 100 mm | Withdrawn |
| 2039-2020-A | Length 20 mm | Withdrawn |
| 2039-2520-A | Length 20 mm | Withdrawn |
| 2237-50100 | Length 100 mm | Withdrawn |
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 |
| Scoreflex PTA Scoring Balloon Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | 58 |
| 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.