510(k) K193495
K193495 is an FDA 510(k) premarket notification submitted by Transit Scientific for the device "XO Score Percutaneous Transluminal Angioplasty Scoring Catheter". The FDA issued a decision of Substantially Equivalent on May 29, 2020. The device falls under product code PNO (Catheter, Percutaneous, Cutting/Scoring), a Class II device regulated under 21 CFR 870.1250. Transit Scientific has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 29, 2020
- Date Received
- December 17, 2019
- Clearance Type
- Traditional
- 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