FDA 510(k)

BD Acute Central Line

K-Number: K190855 · 2019-11-01

ApplicantBard Access Systems, Inc. (Bard Has Joined Bd)

Decision Date2019-11-01

Product CodeFOZ

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

BD Acute Central Line is the device name listed in this FDA 510(k) record. The listed applicant is Bard Access Systems, Inc. (Bard Has Joined Bd). It received FDA 510(k) clearance on 2019-11-01 under 510(k) number K190855. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BD Acute Central Line?

BD Acute Central Line is a medical device that received FDA 510(k) clearance on 2019-11-01. The listed applicant is Bard Access Systems, Inc. (Bard Has Joined Bd). The 510(k) number is K190855.

When did BD Acute Central Line receive FDA 510(k) clearance?

BD Acute Central Line received FDA 510(k) clearance on 2019-11-01, under 510(k) number K190855.

Who is the listed applicant for BD Acute Central Line?

The FDA 510(k) record lists Bard Access Systems, Inc. (Bard Has Joined Bd) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD Acute Central Line?

The FDA product code for BD Acute Central Line is FOZ.

Other records listing Bard Access Systems, Inc. (Bard Has Joined Bd) as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K200266BD Centro Vena Acute Central Line (7 French Dual Lumen)

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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.