2cm Peripheral Cutting Balloon Microsurgical Dilatation Catheter— 510(k) K151253
Substantially EquivalentBoston Scientific Limited
FDA 510(k) clearance K151253 for 2cm Peripheral Cutting Balloon Microsurgical Dilatation Catheter, Substantially Equivalent on 2015-06-10. Applicant: Boston Scientific Limited. Device class: 2.
Clearance details
- Applicant
- Boston Scientific Limited
- Product code
- Code PNO
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Galway, IE
Recent devices under product code PNO
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- K243944 — Aperta NSE PTA Balloon Dilatation Catheter
- K242254 — D·Kutting LL Peripheral Scoring Balloon Dilatation Catheter
- K241478 — Tri-Wedge PTA Scoring Balloon Dilatation Catheter
- K232258 — XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter
Adverse events under product code PNO
product code PNO- Malfunction
- 1,646
- Total
- 1,646
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.