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FDA 510(k)

Rapid LVO

K-Number: K221248 · 2022-05-31

ApplicantIschemaview, Inc.
Decision Date2022-05-31
Product CodeQAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Rapid LVO is a medical device manufactured by Ischemaview, Inc.. It received FDA 510(k) clearance on 2022-05-31 under approval number K221248. The device is classified under product code QAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rapid LVO?

Rapid LVO is a medical device that received FDA 510(k) clearance on 2022-05-31. It is manufactured by Ischemaview, Inc.. The 510(k) number is K221248.

When was Rapid LVO approved by the FDA?

Rapid LVO received FDA 510(k) clearance on 2022-05-31, under approval number K221248.

What company makes Rapid LVO?

Rapid LVO is manufactured by Ischemaview, Inc..

What is the FDA product code for Rapid LVO?

The FDA product code for Rapid LVO is QAS.

Other Devices by Ischemaview, Inc.

K182130iSchemaView RAPID K172477iSchemaView RAPID K200941Rapid LVO K200760Rapid ASPECTS K221456Rapid ICH K220499Rapid PE Triage and Notification (PETN)

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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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