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FDA 510(k)

MIDAScope and Introducer Kit, and MIDASystem

K-Number: K181982 · 2018-08-21

ApplicantIntravu, Inc.
Decision Date2018-08-21
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MIDAScope and Introducer Kit, and MIDASystem is the device name listed in this FDA 510(k) record. The listed applicant is Intravu, Inc.. It received FDA 510(k) clearance on 2018-08-21 under 510(k) 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. The listed applicant is Intravu, Inc.. The 510(k) number is K181982.

When did MIDAScope and Introducer Kit, and MIDASystem receive FDA 510(k) clearance?

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

Who is the listed applicant for MIDAScope and Introducer Kit, and MIDASystem?

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

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 records listing Intravu, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243020MIDASVu

Related Devices (Code: HRX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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