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FDA 510(k)

NEUROSCOUT STEERABLE GUIDEWIRE

K-Number: K100351 · 2010-03-16

ApplicantCodman & Shurtleff, Inc.
Decision Date2010-03-16
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NEUROSCOUT STEERABLE GUIDEWIRE is the device name listed in this FDA 510(k) record. The listed applicant is Codman & Shurtleff, Inc.. It received FDA 510(k) clearance on 2010-03-16 under 510(k) number K100351. 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 NEUROSCOUT STEERABLE GUIDEWIRE?

NEUROSCOUT STEERABLE GUIDEWIRE is a medical device that received FDA 510(k) clearance on 2010-03-16. The listed applicant is Codman & Shurtleff, Inc.. The 510(k) number is K100351.

When did NEUROSCOUT STEERABLE GUIDEWIRE receive FDA 510(k) clearance?

NEUROSCOUT STEERABLE GUIDEWIRE received FDA 510(k) clearance on 2010-03-16, under 510(k) number K100351.

Who is the listed applicant for NEUROSCOUT STEERABLE GUIDEWIRE?

The FDA 510(k) record lists Codman & Shurtleff, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEUROSCOUT STEERABLE GUIDEWIRE?

The FDA product code for NEUROSCOUT STEERABLE GUIDEWIRE 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.

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