2 CM PERIPHERAL CUTTING BALOON— 510(k) K041993
Substantially EquivalentBoston Scientific Ivt
FDA 510(k) clearance K041993 for 2 CM PERIPHERAL CUTTING BALOON, Substantially Equivalent on 2004-08-16. Applicant: Boston Scientific Ivt. Device class: 2.
Clearance details
- Applicant
- Boston Scientific Ivt
- 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
- San Diego, CA, US
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More clearances from Boston Scientific Ivt
view allAdverse 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.