FDA 510(k)

MIDAScope and Introducer Kit, and MIDASystem

K-Number: K181982 · 2018-08-21

Decision Date2018-08-21

Product CodeHRX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

MIDAScope and Introducer Kit, and MIDASystem is a medical device manufactured by Intravu, Inc.. It received FDA 510(k) clearance on 2018-08-21 under approval number K181982. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MIDAScope and Introducer Kit, and MIDASystem?

MIDAScope and Introducer Kit, and MIDASystem is a medical device that received FDA 510(k) clearance on 2018-08-21. It is manufactured by Intravu, Inc.. The 510(k) number is K181982.

When was MIDAScope and Introducer Kit, and MIDASystem approved by the FDA?

MIDAScope and Introducer Kit, and MIDASystem received FDA 510(k) clearance on 2018-08-21, under approval number K181982.

What company makes MIDAScope and Introducer Kit, and MIDASystem?

MIDAScope and Introducer Kit, and MIDASystem is manufactured by Intravu, Inc..

What is the FDA product code for MIDAScope and Introducer Kit, and MIDASystem?

The FDA product code for MIDAScope and Introducer Kit, and MIDASystem is HRX.

Other Devices by Intravu, Inc.

K243020MIDASVu

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.