Home › Device types › PNO
Catheter, Percutaneous, Cutting/Scoring
FDA product code PNO · Class 2 · Cardiovascular
813
Registered devices
2,160
Adverse events
3
Recalls
46
510(k) clearances
Devices with this code
Scoreflex PTA Scoring Balloon Catheter — OrbusNeich Medical (ShenZhen) Co., Ltd.Scoreflex PTA Scoring Balloon Catheter — OrbusNeich Medical (ShenZhen) Co., Ltd.Small Peripheral Cutting Balloon® — BOSTON SCIENTIFIC CORPORATIONVascuTrak® — Bard Peripheral Vascular, Inc.VascuTrak® — Bard Peripheral Vascular, Inc.Scoreflex PTA Scoring Balloon Catheter — OrbusNeich Medical (ShenZhen) Co., Ltd.VascuTrak® — Bard Peripheral Vascular, Inc.ULTRASCORE — Bard Peripheral Vascular, Inc.ULTRASCORE — Bard Peripheral Vascular, Inc.Scoreflex PTA Scoring Balloon Catheter — OrbusNeich Medical (ShenZhen) Co., Ltd.Scoreflex PTA Scoring Balloon Catheter — OrbusNeich Medical (ShenZhen) Co., Ltd.PTA Scoring Balloon Dilatation Catheter — DK Medical Technology Co., Ltd.Scoreflex PTA Scoring Balloon Catheter — OrbusNeich Medical (ShenZhen) Co., Ltd.Tri-Wedge PTA Scoring Balloon Dilatation Catheter — BrosMed Medical Co.,Ltd.Advance Enforcer — COOK INCORPORATEDPTA Scoring Balloon Dilatation Catheter — DK Medical Technology Co., Ltd.ULTRASCORE — Bard Peripheral Vascular, Inc.Serranator — CAGENT VASCULAR, LLCULTRASCORE — Bard Peripheral Vascular, Inc.Tri-Wedge PTA Scoring Balloon Dilatation Catheter — BrosMed Medical Co.,Ltd.Tri-Wedge PTA Scoring Balloon Dilatation Catheter — BrosMed Medical Co.,Ltd.PTA Scoring Balloon Dilatation Catheter — DK Medical Technology Co., Ltd.VascuTrak® — Bard Peripheral Vascular, Inc.PTA Scoring Balloon Dilatation Catheter — DK Medical Technology Co., Ltd.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-05-24 | Cook Inc. | Multiple complaints were received for balloons bursting below the rated burst pressure. Potential adverse events that may occur if an affected product is used |
| 2019-05-24 | Cook Inc. | Multiple complaints were received for balloons bursting below the rated burst pressure. Potential adverse events that may occur if an affected product is used |
| 2019-05-24 | Cook Inc. | Multiple complaints were received for balloons bursting below the rated burst pressure. Potential adverse events that may occur if an affected product is used |
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