FDA 510(k) clearance · back to tracker
TruSelect 2.6 Microcatheter
Boston Scientific Corporation cleared K260771 on 2026-05-15, decision: substantially equivalent
K-number
K260771
Sponsor
Boston Scientific Corporation
Device
TruSelect 2.6 Microcatheter
Class
Class II
Decision
Substantially Equivalent
Decision date
2026-05-15
Product code
KRA
Advisory committee
Cardiovascular
Medical specialty
Cardiovascular
Regulation number
870.1210
Official FDA record
Open K260771on accessdata.fda.gov →
FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.
openFDA JSON
Raw record →
Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.
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Try the sandboxSource
Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.