AngioSculpt OTW PTA Scoring Balloon Catheter With HydroCross Coating
13 catalogue numbers from 2237-50100, listed by The Spectranetics Corp., under Catheter, Percutaneous, Cutting/Scoring. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
13catalogue 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 | The Spectranetics Corp. |
|---|---|
| FDA product code | PNO |
| Device type | Catheter, Percutaneous, Cutting/Scoring |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| Record published | 2016-09-23 |
| Record revised | 2025-05-19 (version 10) |
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 | Special storage condition: Keep Dry |
| Sizes | Balloon length 100 to 200 mm; balloon diameter 2 to 6 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2237-50100 | Balloon Length 100 mm | In distribution |
| 2237-40100 | Balloon Length 100 mm | In distribution |
| 2249-60200 | Balloon Length 200 mm | In distribution |
| 2216-30100 | Balloon Length 100 mm | In distribution |
| 2290-60100 | Balloon Length 100 mm | In distribution |
| 2216-20100 | Balloon Length 100 mm | In distribution |
| 2237-60100 | Balloon Length 100 mm | In distribution |
| 2216-35100 | Balloon Length 100 mm | In distribution |
| 2216-25100 | Balloon Length 100 mm | In distribution |
| 2290-40100 | Balloon Length 100 mm | In distribution |
| 2249-40200 | Balloon Length 200 mm | In distribution |
| 2249-50200 | Balloon Length 200 mm | In distribution |
| 2290-50100 | Balloon Length 100 mm | 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 |
| 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 |
| 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.