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FDA 510(k)

SIR-Spheres Microspheres Activity Calculator (SMAC)

K-Number: K202392 · 2020-10-23

ApplicantSirtex Medical US Holdings, Inc.
Decision Date2020-10-23
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SIR-Spheres Microspheres Activity Calculator (SMAC) is a medical device manufactured by Sirtex Medical US Holdings, Inc.. It received FDA 510(k) clearance on 2020-10-23 under approval number K202392. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIR-Spheres Microspheres Activity Calculator (SMAC)?

SIR-Spheres Microspheres Activity Calculator (SMAC) is a medical device that received FDA 510(k) clearance on 2020-10-23. It is manufactured by Sirtex Medical US Holdings, Inc.. The 510(k) number is K202392.

When was SIR-Spheres Microspheres Activity Calculator (SMAC) approved by the FDA?

SIR-Spheres Microspheres Activity Calculator (SMAC) received FDA 510(k) clearance on 2020-10-23, under approval number K202392.

What company makes SIR-Spheres Microspheres Activity Calculator (SMAC)?

SIR-Spheres Microspheres Activity Calculator (SMAC) is manufactured by Sirtex Medical US Holdings, Inc..

What is the FDA product code for SIR-Spheres Microspheres Activity Calculator (SMAC)?

The FDA product code for SIR-Spheres Microspheres Activity Calculator (SMAC) is KPS.

Related Clinical Trials

NCT02305459 CIRSE Registry for SIR-Spheres Therapy COMPLETED

Related Devices (Code: KPS)

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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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