FDA 510(k)

TRILLIUM MYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM, MODELS 41, 41-B

K-Number: K011864 · 2001-07-09

Decision Date2001-07-09

Product CodeDTN

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

TRILLIUM MYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM, MODELS 41, 41-B is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 2001-07-09 under 510(k) number K011864. The device is classified under product code DTN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRILLIUM MYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM, MODELS 41, 41-B?

TRILLIUM MYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM, MODELS 41, 41-B is a medical device that received FDA 510(k) clearance on 2001-07-09. The listed applicant is Medtronic Vascular. The 510(k) number is K011864.

When did TRILLIUM MYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM, MODELS 41, 41-B receive FDA 510(k) clearance?

TRILLIUM MYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM, MODELS 41, 41-B received FDA 510(k) clearance on 2001-07-09, under 510(k) number K011864.

Who is the listed applicant for TRILLIUM MYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM, MODELS 41, 41-B?

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

What is the FDA product code for TRILLIUM MYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM, MODELS 41, 41-B?

The FDA product code for TRILLIUM MYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM, MODELS 41, 41-B is DTN.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.