FDA 510(k)

AccuCath Ace™ Intravascular Catheter

K-Number: K233106 · 2024-04-19

ApplicantBard Access Systems, Inc. (C.R. Bard, Inc.)

Decision Date2024-04-19

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 Bard Access Systems, Inc. (C.R. Bard, Inc.). It received FDA 510(k) clearance on 2024-04-19 under 510(k) number K233106. 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 2024-04-19. The listed applicant is Bard Access Systems, Inc. (C.R. Bard, Inc.). The 510(k) number is K233106.

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

AccuCath Ace™ Intravascular Catheter received FDA 510(k) clearance on 2024-04-19, under 510(k) number K233106.

Who is the listed applicant for AccuCath Ace™ Intravascular Catheter?

The FDA 510(k) record lists Bard Access Systems, Inc. (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.

Other records listing Bard Access Systems, Inc. (C.R. Bard, Inc.) 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.

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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.