T2 ICF
K-Number: K193366 · 2020-03-20
ApplicantStryker GmbH
Decision Date2020-03-20
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
T2 ICF is a medical device manufactured by Stryker GmbH. It received FDA 510(k) clearance on 2020-03-20 under approval number K193366. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the T2 ICF?
T2 ICF is a medical device that received FDA 510(k) clearance on 2020-03-20. It is manufactured by Stryker GmbH. The 510(k) number is K193366.
When was T2 ICF approved by the FDA?
T2 ICF received FDA 510(k) clearance on 2020-03-20, under approval number K193366.
What company makes T2 ICF?
T2 ICF is manufactured by Stryker GmbH.
What is the FDA product code for T2 ICF?
The FDA product code for T2 ICF is HWC. This falls under the Cardiovascular category.
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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.