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FDA 510(k)

Altapore Shape

K-Number: K191513 · 2019-10-19

Decision Date2019-10-19
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Altapore Shape is a medical device manufactured by Baxter Healthcare Corporation. It received FDA 510(k) clearance on 2019-10-19 under approval number K191513. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Altapore Shape?

Altapore Shape is a medical device that received FDA 510(k) clearance on 2019-10-19. It is manufactured by Baxter Healthcare Corporation. The 510(k) number is K191513.

When was Altapore Shape approved by the FDA?

Altapore Shape received FDA 510(k) clearance on 2019-10-19, under approval number K191513.

What company makes Altapore Shape?

Altapore Shape is manufactured by Baxter Healthcare Corporation.

What is the FDA product code for Altapore Shape?

The FDA product code for Altapore Shape is MQV.

Other Devices by Baxter Healthcare Corporation

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Related Devices (Code: MQV)

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.