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FDA 510(k)

FATHOM 16 STEERABLE GUIDEWIRE MODEL M001509XXX

K-Number: K111485 · 2011-06-30

ApplicantBoston Scientific Corporation
Decision Date2011-06-30
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FATHOM 16 STEERABLE GUIDEWIRE MODEL M001509XXX 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 2011-06-30 under 510(k) number K111485. 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 GUIDEWIRE MODEL M001509XXX?

FATHOM 16 STEERABLE GUIDEWIRE MODEL M001509XXX is a medical device that received FDA 510(k) clearance on 2011-06-30. The listed applicant is Boston Scientific Corporation. The 510(k) number is K111485.

When did FATHOM 16 STEERABLE GUIDEWIRE MODEL M001509XXX receive FDA 510(k) clearance?

FATHOM 16 STEERABLE GUIDEWIRE MODEL M001509XXX received FDA 510(k) clearance on 2011-06-30, under 510(k) number K111485.

Who is the listed applicant for FATHOM 16 STEERABLE GUIDEWIRE MODEL M001509XXX?

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 GUIDEWIRE MODEL M001509XXX?

The FDA product code for FATHOM 16 STEERABLE GUIDEWIRE MODEL M001509XXX 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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