FDA 510(k)

BD MAX CTGCTV2, BD MAX System

K-Number: K182692 · 2019-01-08

Decision Date2019-01-08

Product CodeOUY

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

BD MAX CTGCTV2, BD MAX System is the device name listed in this FDA 510(k) record. The listed applicant is Becton, Dickinson and Company. It received FDA 510(k) clearance on 2019-01-08 under 510(k) number K182692. The device is classified under product code OUY. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BD MAX CTGCTV2, BD MAX System?

BD MAX CTGCTV2, BD MAX System is a medical device that received FDA 510(k) clearance on 2019-01-08. The listed applicant is Becton, Dickinson and Company. The 510(k) number is K182692.

When did BD MAX CTGCTV2, BD MAX System receive FDA 510(k) clearance?

BD MAX CTGCTV2, BD MAX System received FDA 510(k) clearance on 2019-01-08, under 510(k) number K182692.

Who is the listed applicant for BD MAX CTGCTV2, BD MAX System?

The FDA 510(k) record lists Becton, Dickinson and Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD MAX CTGCTV2, BD MAX System?

The FDA product code for BD MAX CTGCTV2, BD MAX System is OUY.

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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.