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FDA 510(k)

Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MIS

K-Number: K241564 · 2024-08-02

ApplicantBaxter Healthcare Corporation
Decision Date2024-08-02
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MIS is a medical device manufactured by Baxter Healthcare Corporation. It received FDA 510(k) clearance on 2024-08-02 under approval number K241564. 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 Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MIS?

Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MIS is a medical device that received FDA 510(k) clearance on 2024-08-02. It is manufactured by Baxter Healthcare Corporation. The 510(k) number is K241564.

When was Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MIS approved by the FDA?

Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MIS received FDA 510(k) clearance on 2024-08-02, under approval number K241564.

What company makes Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MIS?

Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MIS is manufactured by Baxter Healthcare Corporation.

What is the FDA product code for Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MIS?

The FDA product code for Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MIS 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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