510(k) K260771

TruSelect™ 2.6 Microcatheter by Boston Scientific Corporation — Product Code KRA

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