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FDA 510(k)

Altapore Shape

K-Number: K191513 · 2019-10-19

ApplicantBaxter Healthcare Corporation
Decision Date2019-10-19
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Altapore Shape is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corporation. It received FDA 510(k) clearance on 2019-10-19 under 510(k) 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. The listed applicant is Baxter Healthcare Corporation. The 510(k) number is K191513.

When did Altapore Shape receive FDA 510(k) clearance?

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

Who is the listed applicant for Altapore Shape?

The FDA 510(k) record lists Baxter Healthcare Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Altapore Shape?

The FDA product code for Altapore Shape is MQV.

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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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