TruSelect 2.6 Microcatheter— 510(k) K260771
Substantially EquivalentBoston Scientific Corporation
FDA 510(k) clearance K260771 for TruSelect 2.6 Microcatheter, Substantially Equivalent on 2026-05-15. Applicant: Boston Scientific Corporation. Device class: 2.
Summary
Boston Scientific's TruSelect 2.6 Microcatheter is filed under KRA, continuous flush catheters.
Class II, 21 CFR 870.1210. Cardiovascular is both the classification panel and the review panel. It came in as a Special 510(k).
The record spells the city Marborough, Massachusetts. Review took 67 calendar days (March 9 to May 15, 2026).
Clearance details
- Applicant
- Boston Scientific Corporation
- Product code
- Product code KRA
- Device class
- Class 2
- Regulation
- 21 CFR 870.1210
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Marborough, MA, US
Recent devices under product code KRA
view allMore clearances from Boston Scientific Corporation
view allAdverse events under product code KRA
product code KRA- Death
- 234
- Injury
- 1,029
- Malfunction
- 3,012
- Other
- 2
- Total
- 4,277
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.