FDA 510(k) clearance · back to tracker
VIKING Fixed Curve Diagnostic Catheter
Boston Scientific Corporation cleared K250310 on 2025-06-27, decision: substantially equivalent
K-number
K250310
Sponsor
Boston Scientific Corporation
Device
VIKING Fixed Curve Diagnostic Catheter
Class
Class II
Decision
Substantially Equivalent
Decision date
2025-06-27
Product code
DRF
Advisory committee
Cardiovascular
Medical specialty
Cardiovascular
Regulation number
870.1220
Official FDA record
Open K250310on accessdata.fda.gov →
FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.
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Raw record →
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Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.