510(k) K260771
K260771 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "TruSelect 2.6 Microcatheter". The FDA issued a decision of Substantially Equivalent on May 15, 2026. The device falls under product code KRA (Catheter, Continuous Flush), a Class II device regulated under 21 CFR 870.1210. Boston Scientific Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 15, 2026
- Date Received
- March 9, 2026
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Continuous Flush
- Device Class
- Class II
- Regulation Number
- 870.1210
- Review Panel
- CV
- Submission Type