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FDA 510(k)

AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE (IHVLP)

K-Number: K080170 · 2008-03-25

ApplicantC.R. Bard, Inc.
Decision Date2008-03-25
Product CodeBTR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE (IHVLP) is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 2008-03-25 under 510(k) number K080170. 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 AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE (IHVLP)?

AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE (IHVLP) is a medical device that received FDA 510(k) clearance on 2008-03-25. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K080170.

When did AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE (IHVLP) receive FDA 510(k) clearance?

AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE (IHVLP) received FDA 510(k) clearance on 2008-03-25, under 510(k) number K080170.

Who is the listed applicant for AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE (IHVLP)?

The FDA 510(k) record lists C.R. Bard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE (IHVLP)?

The FDA product code for AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE (IHVLP) is BTR.

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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.

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