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FDA 510(k)

TRUSELECT Microcatheter

K-Number: K201792 · 2020-07-28

ApplicantBoston Scientific Corporation
Decision Date2020-07-28
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TRUSELECT Microcatheter is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2020-07-28 under approval number K201792. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRUSELECT Microcatheter?

TRUSELECT Microcatheter is a medical device that received FDA 510(k) clearance on 2020-07-28. It is manufactured by Boston Scientific Corporation. The 510(k) number is K201792.

When was TRUSELECT Microcatheter approved by the FDA?

TRUSELECT Microcatheter received FDA 510(k) clearance on 2020-07-28, under approval number K201792.

What company makes TRUSELECT Microcatheter?

TRUSELECT Microcatheter is manufactured by Boston Scientific Corporation.

What is the FDA product code for TRUSELECT Microcatheter?

The FDA product code for TRUSELECT Microcatheter is KRA.

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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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