ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076 AND 2039— 510(k) K080151
Substantially EquivalentAngioscore, Inc.
FDA 510(k) clearance K080151 for ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076 AND 2039, Substantially Equivalent on 2008-04-25. Applicant: Angioscore, Inc.. Device class: 2.
Clearance details
- Applicant
- Angioscore, Inc.
- 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
- Traditional
- Location
- Fremont, CA, US
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More clearances from Angioscore, Inc.
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.