510(k) K221986
K221986 is an FDA 510(k) premarket notification submitted by Transit Scientific, LLC for the device "XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter". The FDA issued a decision of Substantially Equivalent on October 18, 2022. The device falls under product code PNO (Catheter, Percutaneous, Cutting/Scoring), a Class II device regulated under 21 CFR 870.1250. Transit Scientific, LLC has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 18, 2022
- Date Received
- July 6, 2022
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Percutaneous, Cutting/Scoring
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type
To reduce vascular stenosis by dilatation and apposition of the cutting/scoring surfaces to the stenotic material