Scoreflex PTA Scoring Balloon Catheter— 510(k) K182713
Substantially EquivalentOrbusneich Medical Trading, Inc.
FDA 510(k) clearance K182713 for Scoreflex PTA Scoring Balloon Catheter, Substantially Equivalent on 2019-06-11. Applicant: Orbusneich Medical Trading, Inc..
Clearance details
- Applicant
- Orbusneich Medical Trading, Inc.
- Product code
- Code PNO
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fort Lauderdale, FL, US
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.