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FDA 510(k)

Fathom-16 Steerable Guidewires

K-Number: K170636 · 2017-03-22

ApplicantBoston Scientific Corporation
Decision Date2017-03-22
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Fathom-16 Steerable Guidewires is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2017-03-22 under approval number K170636. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fathom-16 Steerable Guidewires?

Fathom-16 Steerable Guidewires is a medical device that received FDA 510(k) clearance on 2017-03-22. It is manufactured by Boston Scientific Corporation. The 510(k) number is K170636.

When was Fathom-16 Steerable Guidewires approved by the FDA?

Fathom-16 Steerable Guidewires received FDA 510(k) clearance on 2017-03-22, under approval number K170636.

What company makes Fathom-16 Steerable Guidewires?

Fathom-16 Steerable Guidewires is manufactured by Boston Scientific Corporation.

What is the FDA product code for Fathom-16 Steerable Guidewires?

The FDA product code for Fathom-16 Steerable Guidewires is DQX.

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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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