FDA 510(k)

AccuCath Ace Intravascular Catheter

K-Number: K191232 · 2019-09-18

Decision Date2019-09-18

Product CodeFOZ

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

AccuCath Ace Intravascular Catheter is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 2019-09-18 under 510(k) number K191232. 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 AccuCath Ace Intravascular Catheter?

AccuCath Ace Intravascular Catheter is a medical device that received FDA 510(k) clearance on 2019-09-18. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K191232.

When did AccuCath Ace Intravascular Catheter receive FDA 510(k) clearance?

AccuCath Ace Intravascular Catheter received FDA 510(k) clearance on 2019-09-18, under 510(k) number K191232.

Who is the listed applicant for AccuCath Ace Intravascular Catheter?

The FDA 510(k) record lists C.R. Bard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AccuCath Ace Intravascular Catheter?

The FDA product code for AccuCath Ace Intravascular Catheter is FOZ.

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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.