Home › Device types › NWX
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring
FDA product code NWX · Class 3 · Unknown
236
Registered devices
7,737
Adverse events
3
Recalls
0
510(k) clearances
Devices with this code
AngioSculpt®PTCA Scoring Balloon Catheter — Spectranetics CorporationFlextome® Cutting Balloon® — BOSTON SCIENTIFIC CORPORATIONFlextome® Cutting Balloon® — BOSTON SCIENTIFIC CORPORATIONFlextome® Cutting Balloon® — BOSTON SCIENTIFIC CORPORATIONWolverine Coronary Cutting Balloon — BOSTON SCIENTIFIC CORPORATIONFlextome® Cutting Balloon® — BOSTON SCIENTIFIC CORPORATIONScoreflex NC Scoring PTCA Catheter — OrbusNeich Medical (ShenZhen) Co., Ltd.AngioSculpt® PTCA Scoring Balloon Catheter — Angioscore Inc.AngioSculpt PTCA RX Scoring Balloon Catheter — Spectranetics CorporationWolverine Coronary Cutting Balloon — BOSTON SCIENTIFIC CORPORATIONScoreflex NC Scoring PTCA Catheter — OrbusNeich Medical (ShenZhen) Co., Ltd.AngioSculpt® PTCA Scoring Balloon Catheter — Angioscore Inc.AngioSculpt PTCA RX Scoring Balloon Catheter — Spectranetics CorporationScoreflex NC Scoring PTCA Catheter — OrbusNeich Medical (ShenZhen) Co., Ltd.AngioSculpt Evo RX PTCA scoring balloon catheter with hydrophilic coating — Philips Image Guided Therapy CorporationAngioSculpt® PTCA Scoring Balloon Catheter — Angioscore Inc.Flextome® Cutting Balloon® — BOSTON SCIENTIFIC CORPORATIONAngioSculpt®PTCA Scoring Balloon Catheter — Spectranetics CorporationAngioSculpt® PTCA Scoring Balloon Catheter — Angioscore Inc.AngioSculpt®PTCA Scoring Balloon Catheter — Spectranetics CorporationAngioSculpt® PTCA Scoring Balloon Catheter — Angioscore Inc.AngioSculpt®PTCA Scoring Balloon Catheter — Spectranetics CorporationAngioSculpt® PTCA Scoring Balloon Catheter — Angioscore Inc.Scoreflex NC Scoring PTCA Catheter — OrbusNeich Medical (ShenZhen) Co., Ltd.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-12-07 | Spectranetics Corporation | The incorrect outer carton box was used for the product. |
| 2009-12-04 | AngioScore Inc. | Separations of the PTCA catheter shaft at the guide wire exit port have occurred during treatment of coronary artery stenosis. Fragments of the catheter may bec |
| 2007-11-13 | AngioScore Inc. | Mis-labeling: Product labeling on product pouch indicates wrong size, the correct size is on the product carton |
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