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FDA 510(k)

TRELLIS-8 PERIPHERAL INFUSION SYSTEM

K-Number: K130904 · 2013-10-25

ApplicantCovidien
Decision Date2013-10-25
Product CodeQEY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TRELLIS-8 PERIPHERAL INFUSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Covidien. It received FDA 510(k) clearance on 2013-10-25 under 510(k) number K130904. The device is classified under product code QEY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRELLIS-8 PERIPHERAL INFUSION SYSTEM?

TRELLIS-8 PERIPHERAL INFUSION SYSTEM is a medical device that received FDA 510(k) clearance on 2013-10-25. The listed applicant is Covidien. The 510(k) number is K130904.

When did TRELLIS-8 PERIPHERAL INFUSION SYSTEM receive FDA 510(k) clearance?

TRELLIS-8 PERIPHERAL INFUSION SYSTEM received FDA 510(k) clearance on 2013-10-25, under 510(k) number K130904.

Who is the listed applicant for TRELLIS-8 PERIPHERAL INFUSION SYSTEM?

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

What is the FDA product code for TRELLIS-8 PERIPHERAL INFUSION SYSTEM?

The FDA product code for TRELLIS-8 PERIPHERAL INFUSION SYSTEM is QEY.

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Related Devices (Code: QEY)

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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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