FDA 510(k)

KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING

K-Number: K120985 · 2012-12-19

Decision Date2012-12-19

Product CodeBTR

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING is the device name listed in this FDA 510(k) record. The listed applicant is Kimberly-Clark Corp.. It received FDA 510(k) clearance on 2012-12-19 under 510(k) number K120985. The device is classified under product code BTR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING?

KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING is a medical device that received FDA 510(k) clearance on 2012-12-19. The listed applicant is Kimberly-Clark Corp.. The 510(k) number is K120985.

When did KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING receive FDA 510(k) clearance?

KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING received FDA 510(k) clearance on 2012-12-19, under 510(k) number K120985.

Who is the listed applicant for KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING?

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

What is the FDA product code for KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING?

The FDA product code for KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING is BTR.

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Other records listing Kimberly-Clark Corp. as applicant

K131879KC 300 SURGICAL MASK K131841KIMBERLY-CLARK LAVENDER NITRILE POWDER-FREE EXAM GLOVE K131254KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE K112805KIMGUARD ONE-STEP STERILIZATION WRAP K113423KIMBERLY CLARK PURPLE NITRILE, AND PURPLE NITRILE XTRA POWDER FREE EXAM GLOVE K112300KIMGUARD SMART-FOLD* STERILIZATION WRAP

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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.