Decision Date2007-11-06
Product CodeBTR
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE 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 2007-11-06 under 510(k) number K071365. 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?
AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE is a medical device that received FDA 510(k) clearance on 2007-11-06. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K071365.
When did AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE receive FDA 510(k) clearance?
AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE received FDA 510(k) clearance on 2007-11-06, under 510(k) number K071365.
Who is the listed applicant for AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE?
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?
The FDA product code for AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE is BTR.
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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.