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FDA 510(k)

MR Compatible Aspiration Kit

K-Number: K181731 · 2018-11-20

ApplicantMri Interventions, Inc.
Decision Date2018-11-20
Product CodeGWG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MR Compatible Aspiration Kit is the device name listed in this FDA 510(k) record. The listed applicant is Mri Interventions, Inc.. It received FDA 510(k) clearance on 2018-11-20 under 510(k) number K181731. The device is classified under product code GWG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MR Compatible Aspiration Kit?

MR Compatible Aspiration Kit is a medical device that received FDA 510(k) clearance on 2018-11-20. The listed applicant is Mri Interventions, Inc.. The 510(k) number is K181731.

When did MR Compatible Aspiration Kit receive FDA 510(k) clearance?

MR Compatible Aspiration Kit received FDA 510(k) clearance on 2018-11-20, under 510(k) number K181731.

Who is the listed applicant for MR Compatible Aspiration Kit?

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

What is the FDA product code for MR Compatible Aspiration Kit?

The FDA product code for MR Compatible Aspiration Kit is GWG.

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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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