510(k) K182713
K182713 is an FDA 510(k) premarket notification submitted by Orbusneich Medical Trading, Inc. for the device "Scoreflex PTA Scoring Balloon Catheter". The FDA issued a decision of Substantially Equivalent on June 11, 2019. The device falls under product code PNO (Catheter, Percutaneous, Cutting/Scoring), a Class II device regulated under 21 CFR 870.1250. Orbusneich Medical Trading, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 11, 2019
- Date Received
- September 27, 2018
- 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