FDA 510(k)

INSYTE ARTCATH ARTERIAL CATHETERIZATION UNIT

K-Number: K921845 · 1992-11-10

ApplicantBecton Dickinson Vascular Access, Inc.

Decision Date1992-11-10

Product CodeDQO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

INSYTE ARTCATH ARTERIAL CATHETERIZATION UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Becton Dickinson Vascular Access, Inc.. It received FDA 510(k) clearance on 1992-11-10 under 510(k) number K921845. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INSYTE ARTCATH ARTERIAL CATHETERIZATION UNIT?

INSYTE ARTCATH ARTERIAL CATHETERIZATION UNIT is a medical device that received FDA 510(k) clearance on 1992-11-10. The listed applicant is Becton Dickinson Vascular Access, Inc.. The 510(k) number is K921845.

When did INSYTE ARTCATH ARTERIAL CATHETERIZATION UNIT receive FDA 510(k) clearance?

INSYTE ARTCATH ARTERIAL CATHETERIZATION UNIT received FDA 510(k) clearance on 1992-11-10, under 510(k) number K921845.

Who is the listed applicant for INSYTE ARTCATH ARTERIAL CATHETERIZATION UNIT?

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

What is the FDA product code for INSYTE ARTCATH ARTERIAL CATHETERIZATION UNIT?

The FDA product code for INSYTE ARTCATH ARTERIAL CATHETERIZATION UNIT is DQO.

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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.