Small Peripheral Cutting Balloon®
Microsurgical Dilatation Device
3manufacturers in China registered for this device type
10catalogue numbers in this listing
4510(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 | Boston Scientific Corporation, United States |
|---|---|
| FDA product code | PNO |
| Device type | Catheter, Percutaneous, Cutting/Scoring |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-24 |
| Record revised | 2019-08-09 (version 3) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M001PCBM4015140F0 | 4.0 mm Diameter | In distribution |
| M001PCBM2515140F0 | 142 cm Effective Length | In distribution |
| M001PCBM3515140F0 | 3.5 mm Diameter | In distribution |
| M001PCBO2015140F0 | 2.0 mm Diameter | In distribution |
| M001PCBM3015140F0 | 1.5 cm Length | In distribution |
| M001PCBO2515140F0 | 1.5 cm Length | In distribution |
| M001PCBM2015140F0 | 2.0 mm Diameter | In distribution |
| M001PCBO4015140F0 | 4.0 mm Diameter | In distribution |
| M001PCBO3015140F0 | 3.0 mm Diameter | In distribution |
| M001PCBO3515140F0 | 137 cm Effective Length | 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 |
| 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 |
Showing 12 of 16. All products under Catheter, Percutaneous, Cutting/Scoring
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K151253 | 2015-06-10 |
| K070951 | 2007-06-04 |
| K062387 | 2006-10-05 |
| K040155 | 2004-07-01 |
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.