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FDA 510(k)

Direxion and Direxion HI-FLO Torqueable Microcatheters

K-Number: K163701 · 2017-05-16

ApplicantBoston Scientific Corporation
Decision Date2017-05-16
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Direxion and Direxion HI-FLO Torqueable Microcatheters is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2017-05-16 under approval number K163701. 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 Direxion and Direxion HI-FLO Torqueable Microcatheters?

Direxion and Direxion HI-FLO Torqueable Microcatheters is a medical device that received FDA 510(k) clearance on 2017-05-16. It is manufactured by Boston Scientific Corporation. The 510(k) number is K163701.

When was Direxion and Direxion HI-FLO Torqueable Microcatheters approved by the FDA?

Direxion and Direxion HI-FLO Torqueable Microcatheters received FDA 510(k) clearance on 2017-05-16, under approval number K163701.

What company makes Direxion and Direxion HI-FLO Torqueable Microcatheters?

Direxion and Direxion HI-FLO Torqueable Microcatheters is manufactured by Boston Scientific Corporation.

What is the FDA product code for Direxion and Direxion HI-FLO Torqueable Microcatheters?

The FDA product code for Direxion and Direxion HI-FLO Torqueable Microcatheters 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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