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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Stryker GmbH. It received FDA 510(k) clearance on 2020-03-20 under 510(k) 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. The listed applicant is Stryker GmbH. The 510(k) number is K193366.

When did T2 ICF receive FDA 510(k) clearance?

T2 ICF received FDA 510(k) clearance on 2020-03-20, under 510(k) number K193366.

Who is the listed applicant for T2 ICF?

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

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.

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