FDA 510(k)

Fathom-16 Steerable Guidewires

K-Number: K170636 · 2017-03-22

Decision Date2017-03-22

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Fathom-16 Steerable Guidewires is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2017-03-22 under 510(k) 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. The listed applicant is Boston Scientific Corporation. The 510(k) number is K170636.

When did Fathom-16 Steerable Guidewires receive FDA 510(k) clearance?

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

Who is the listed applicant for Fathom-16 Steerable Guidewires?

The FDA 510(k) record lists Boston Scientific Corporation as the applicant. This does not by itself establish the device manufacturer.

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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Related Devices (Code: 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.