FDA 510(k)

Miethke Shunt System GAV 2.0 and SA 2.0 Valves

K-Number: K190174 · 2019-07-05

Decision Date2019-07-05

Product CodeJXG

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Miethke Shunt System GAV 2.0 and SA 2.0 Valves is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap, Inc.. It received FDA 510(k) clearance on 2019-07-05 under 510(k) number K190174. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Miethke Shunt System GAV 2.0 and SA 2.0 Valves?

Miethke Shunt System GAV 2.0 and SA 2.0 Valves is a medical device that received FDA 510(k) clearance on 2019-07-05. The listed applicant is Aesculap, Inc.. The 510(k) number is K190174.

When did Miethke Shunt System GAV 2.0 and SA 2.0 Valves receive FDA 510(k) clearance?

Miethke Shunt System GAV 2.0 and SA 2.0 Valves received FDA 510(k) clearance on 2019-07-05, under 510(k) number K190174.

Who is the listed applicant for Miethke Shunt System GAV 2.0 and SA 2.0 Valves?

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

What is the FDA product code for Miethke Shunt System GAV 2.0 and SA 2.0 Valves?

The FDA product code for Miethke Shunt System GAV 2.0 and SA 2.0 Valves is JXG.

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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.