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FDA 510(k)

PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEIVER

K-Number: K113584 · 2012-03-02

ApplicantSt Jude Medical
Decision Date2012-03-02
Product CodeDXO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEIVER is the device name listed in this FDA 510(k) record. The listed applicant is St Jude Medical. It received FDA 510(k) clearance on 2012-03-02 under 510(k) number K113584. The device is classified under product code DXO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEIVER?

PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEIVER is a medical device that received FDA 510(k) clearance on 2012-03-02. The listed applicant is St Jude Medical. The 510(k) number is K113584.

When did PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEIVER receive FDA 510(k) clearance?

PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEIVER received FDA 510(k) clearance on 2012-03-02, under 510(k) number K113584.

Who is the listed applicant for PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEIVER?

The FDA 510(k) record lists St Jude Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEIVER?

The FDA product code for PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEIVER is DXO.

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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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