FDA 510(k)

COOPDECH ENDOBRONCHIAL BLOCKER TUBE, MODELS BBT-A30XXX, BBT-B30XXX

K-Number: K071694 · 2008-03-20

Decision Date2008-03-20

Product CodeCBI

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

COOPDECH ENDOBRONCHIAL BLOCKER TUBE, MODELS BBT-A30XXX, BBT-B30XXX is the device name listed in this FDA 510(k) record. The listed applicant is Daiken Medical Co, Ltd.. It received FDA 510(k) clearance on 2008-03-20 under 510(k) number K071694. The device is classified under product code CBI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COOPDECH ENDOBRONCHIAL BLOCKER TUBE, MODELS BBT-A30XXX, BBT-B30XXX?

COOPDECH ENDOBRONCHIAL BLOCKER TUBE, MODELS BBT-A30XXX, BBT-B30XXX is a medical device that received FDA 510(k) clearance on 2008-03-20. The listed applicant is Daiken Medical Co, Ltd.. The 510(k) number is K071694.

When did COOPDECH ENDOBRONCHIAL BLOCKER TUBE, MODELS BBT-A30XXX, BBT-B30XXX receive FDA 510(k) clearance?

COOPDECH ENDOBRONCHIAL BLOCKER TUBE, MODELS BBT-A30XXX, BBT-B30XXX received FDA 510(k) clearance on 2008-03-20, under 510(k) number K071694.

Who is the listed applicant for COOPDECH ENDOBRONCHIAL BLOCKER TUBE, MODELS BBT-A30XXX, BBT-B30XXX?

The FDA 510(k) record lists Daiken Medical Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COOPDECH ENDOBRONCHIAL BLOCKER TUBE, MODELS BBT-A30XXX, BBT-B30XXX?

The FDA product code for COOPDECH ENDOBRONCHIAL BLOCKER TUBE, MODELS BBT-A30XXX, BBT-B30XXX is CBI.

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Other records listing Daiken Medical Co, Ltd. as applicant

K093888COOPDECH ENDOBRONCHIAL BLOCKER TUBE

Related Devices (Code: CBI)

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.