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FDA 510(k)

BD MAX CTGCTV2, BD MAX System

K-Number: K182692 · 2019-01-08

ApplicantBecton, Dickinson and Company
Decision Date2019-01-08
Product CodeOUY
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

BD MAX CTGCTV2, BD MAX System is a medical device manufactured by Becton, Dickinson and Company. It received FDA 510(k) clearance on 2019-01-08 under approval 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. It is manufactured by Becton, Dickinson and Company. The 510(k) number is K182692.

When was BD MAX CTGCTV2, BD MAX System approved by the FDA?

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

What company makes BD MAX CTGCTV2, BD MAX System?

BD MAX CTGCTV2, BD MAX System is manufactured by Becton, Dickinson and Company.

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.

Related PubMed Literature

PMID: 38815918 What is the MAUDE Database Telling us about 510(k) Authorization? Evaluation of Two Generations of Endovascular Arteriovenous Fistula Devices. Annals of vascular surgery (2024)

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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.

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