XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter— 510(k) K221986
Substantially EquivalentTransit Scientific, LLC
FDA 510(k) clearance K221986 for XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter, Substantially Equivalent on 2022-10-18. Applicant: Transit Scientific, LLC.
Clearance details
- Applicant
- Transit Scientific, LLC
- Product code
- Code PNO
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- 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.