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FDA 510(k)

Rapid LVO

K-Number: K200941 · 2020-07-09

ApplicantIschemaview, Inc.
Decision Date2020-07-09
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 2020-07-09 under approval number K200941. 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 2020-07-09. It is manufactured by Ischemaview, Inc.. The 510(k) number is K200941.

When was Rapid LVO approved by the FDA?

Rapid LVO received FDA 510(k) clearance on 2020-07-09, under approval number K200941.

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 K200760Rapid ASPECTS K221456Rapid ICH K221248Rapid LVO 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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