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FDA 510(k)

MICROGARD II

K-Number: K111408 · 2011-10-17

ApplicantCarefusion Germany 234 GmbH
Decision Date2011-10-17
Product CodeCAH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MICROGARD II is the device name listed in this FDA 510(k) record. The listed applicant is Carefusion Germany 234 GmbH. It received FDA 510(k) clearance on 2011-10-17 under 510(k) number K111408. The device is classified under product code CAH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROGARD II?

MICROGARD II is a medical device that received FDA 510(k) clearance on 2011-10-17. The listed applicant is Carefusion Germany 234 GmbH. The 510(k) number is K111408.

When did MICROGARD II receive FDA 510(k) clearance?

MICROGARD II received FDA 510(k) clearance on 2011-10-17, under 510(k) number K111408.

Who is the listed applicant for MICROGARD II?

The FDA 510(k) record lists Carefusion Germany 234 GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICROGARD II?

The FDA product code for MICROGARD II is CAH.

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Other records listing Carefusion Germany 234 GmbH as applicant

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Related Devices (Code: CAH)

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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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