Panels › Cardiovascular › Product code PNO · Class 2
Catheter, Percutaneous, Cutting/Scoring
Regulation 870.1250
3510(k)s in 12 months (47 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in PNO
| Company | 510(k)s | Recalls |
|---|---|---|
| Angioscore, Inc. | 13 | 0 |
| Cagent Vascular, LLC | 5 | 0 |
| Boston Scientific | 4 | 0 |
| Cook Incorporated | 1 | 3 |
| Transit Scientific | 3 | 0 |
| Bard Peripheral Vascular, Inc. | 2 | 0 |
| Boston Scientific Ivt | 2 | 0 |
| C. R. Bard | 2 | 0 |
| Dk Medical Technology Co., Ltd. | 2 | 0 |
| Goodman Co., Ltd. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 17, 2019 | Cook Inc. Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/135cm, Catalog Number ASB5-35-135-6-4, REF Number G35257
Product Usage:
The Advance Enforcer 35 Focal-Force PTA Balloon Catheter is Terminated |
PNO | K141322 |
| Jun 17, 2019 | Cook Inc. Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/80cm, Catalog Number ASB5-35-80-6-4, REF Number G35252
Product Usage:
The Advance Enforcer 35 Focal-Force PTA Balloon Catheter is i Terminated |
PNO | K141322 |
| Jun 17, 2019 | Cook Inc. Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/50cm, Catalog Number ASB5-35-50-6-4, REF Number G35248
Product Usage:
The Advance Enforcer 35 Focal-Force PTA Balloon Catheter is i Terminated |
PNO | K141322 |
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