XO Score Percutaneous Transluminal Angioplasty Scoring Catheter— 510(k) K193495
Substantially EquivalentTransit Scientific
FDA 510(k) clearance K193495 for XO Score Percutaneous Transluminal Angioplasty Scoring Catheter, Substantially Equivalent on 2020-05-29. Applicant: Transit Scientific.
Clearance details
- Applicant
- Transit Scientific
- Product code
- Code PNO
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Salt Lake City, UT, 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.