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FDA 510(k)

Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional

K-Number: K221333 · 2022-12-29

ApplicantAcumed, LLC
Decision Date2022-12-29
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional is a medical device manufactured by Acumed, LLC. It received FDA 510(k) clearance on 2022-12-29 under approval number K221333. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional?

Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional is a medical device that received FDA 510(k) clearance on 2022-12-29. It is manufactured by Acumed, LLC. The 510(k) number is K221333.

When was Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional approved by the FDA?

Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional received FDA 510(k) clearance on 2022-12-29, under approval number K221333.

What company makes Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional?

Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional is manufactured by Acumed, LLC.

What is the FDA product code for Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional?

The FDA product code for Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional is HWC. This falls under the Cardiovascular category.

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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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