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FDA 510(k)

VIKING™ Fixed Curve Diagnostic Catheter

K-Number: K250310 · 2025-06-27

ApplicantBoston Scientific Corporation
Decision Date2025-06-27
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VIKING™ Fixed Curve Diagnostic Catheter is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2025-06-27 under approval number K250310. The device is classified under product code DRF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIKING™ Fixed Curve Diagnostic Catheter?

VIKING™ Fixed Curve Diagnostic Catheter is a medical device that received FDA 510(k) clearance on 2025-06-27. It is manufactured by Boston Scientific Corporation. The 510(k) number is K250310.

When was VIKING™ Fixed Curve Diagnostic Catheter approved by the FDA?

VIKING™ Fixed Curve Diagnostic Catheter received FDA 510(k) clearance on 2025-06-27, under approval number K250310.

What company makes VIKING™ Fixed Curve Diagnostic Catheter?

VIKING™ Fixed Curve Diagnostic Catheter is manufactured by Boston Scientific Corporation.

What is the FDA product code for VIKING™ Fixed Curve Diagnostic Catheter?

The FDA product code for VIKING™ Fixed Curve Diagnostic Catheter is DRF.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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