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FDA 510(k)

BAL CATH BRONCHIAL ASPIRATE SAMPLING CATHETER

K-Number: K112562 · 2011-12-15

ApplicantKimberly-Clark
Decision Date2011-12-15
Product CodeOYI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BAL CATH BRONCHIAL ASPIRATE SAMPLING CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Kimberly-Clark. It received FDA 510(k) clearance on 2011-12-15 under 510(k) number K112562. The device is classified under product code OYI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BAL CATH BRONCHIAL ASPIRATE SAMPLING CATHETER?

BAL CATH BRONCHIAL ASPIRATE SAMPLING CATHETER is a medical device that received FDA 510(k) clearance on 2011-12-15. The listed applicant is Kimberly-Clark. The 510(k) number is K112562.

When did BAL CATH BRONCHIAL ASPIRATE SAMPLING CATHETER receive FDA 510(k) clearance?

BAL CATH BRONCHIAL ASPIRATE SAMPLING CATHETER received FDA 510(k) clearance on 2011-12-15, under 510(k) number K112562.

Who is the listed applicant for BAL CATH BRONCHIAL ASPIRATE SAMPLING CATHETER?

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

What is the FDA product code for BAL CATH BRONCHIAL ASPIRATE SAMPLING CATHETER?

The FDA product code for BAL CATH BRONCHIAL ASPIRATE SAMPLING CATHETER is OYI.

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Other records listing Kimberly-Clark as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K113340KIMBERLY-CLARK CHILD'S FACEMASKK111402KC200, SURGICAL MASK, KC200, PROCEDURE MASK, KC300, SURGICALMASK, FLUIDSHIELD, KC300, PROCEDURE MASK, FLUIDSHIELD MODELK103150KIMBERLY-CLARK CHILD/PEDIATRIC FACE MASKK101596KIMBERLY-CLARK PURPLE NITRILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) AND KIMBERLY-CLARK PURPLE NITRILE XTRA POWDER-

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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