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FDA 510(k)

CSMC Cardiac Suite

K-Number: K172609 · 2017-11-03

ApplicantCedars-Sinai Medical Center
Decision Date2017-11-03
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CSMC Cardiac Suite is a medical device manufactured by Cedars-Sinai Medical Center. It received FDA 510(k) clearance on 2017-11-03 under approval number K172609. 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 CSMC Cardiac Suite?

CSMC Cardiac Suite is a medical device that received FDA 510(k) clearance on 2017-11-03. It is manufactured by Cedars-Sinai Medical Center. The 510(k) number is K172609.

When was CSMC Cardiac Suite approved by the FDA?

CSMC Cardiac Suite received FDA 510(k) clearance on 2017-11-03, under approval number K172609.

What company makes CSMC Cardiac Suite?

CSMC Cardiac Suite is manufactured by Cedars-Sinai Medical Center.

What is the FDA product code for CSMC Cardiac Suite?

The FDA product code for CSMC Cardiac Suite is 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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