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FDA 510(k)

Rapid RV/LV

K-Number: K223396 · 2023-02-01

ApplicantIschemaview, Inc.
Decision Date2023-02-01
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Rapid RV/LV is a medical device manufactured by Ischemaview, Inc.. It received FDA 510(k) clearance on 2023-02-01 under approval number K223396. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rapid RV/LV?

Rapid RV/LV is a medical device that received FDA 510(k) clearance on 2023-02-01. It is manufactured by Ischemaview, Inc.. The 510(k) number is K223396.

When was Rapid RV/LV approved by the FDA?

Rapid RV/LV received FDA 510(k) clearance on 2023-02-01, under approval number K223396.

What company makes Rapid RV/LV?

Rapid RV/LV is manufactured by Ischemaview, Inc..

What is the FDA product code for Rapid RV/LV?

The FDA product code for Rapid RV/LV is QIH.

Other Devices by Ischemaview, Inc.

K182130iSchemaView RAPID K172477iSchemaView RAPID K200941Rapid LVO K200760Rapid ASPECTS K221456Rapid ICH K221248Rapid LVO

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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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