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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 a medical device manufactured by Bard Access Systems, Inc. (C.R. Bard, Inc.). It received FDA 510(k) clearance on 2024-04-19 under approval 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. It is manufactured by Bard Access Systems, Inc. (C.R. Bard, Inc.). The 510(k) number is K233106.

When was AccuCath Ace™ Intravascular Catheter approved by the FDA?

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

What company makes AccuCath Ace™ Intravascular Catheter?

AccuCath Ace™ Intravascular Catheter is manufactured by Bard Access Systems, Inc. (C.R. Bard, Inc.).

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

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

Related Clinical Trials

NCT07095660 RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-IRL) RECRUITING NCT06662500 FORWARD CAD IDE Study RECRUITING NCT07219758 RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-UK) RECRUITING

Other Devices by Bard Access Systems, Inc. (C.R. Bard, Inc.)

K211193BD Prevue II Peripheral Vascular Vascular Access System K231283SiteRite™ 9 Ultrasound System

Related Devices (Code: FOZ)

K162894AccuCath Intravascular CatheterC.R. Bard, Inc. K161779MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV CatheterMedsource International, LLC K162377PowerGlide Pro Midline CatheterC.R. Bard, Inc. K161866BioFlo Midline CatheterNavilyst Medical, Inc. K161777BD Nexiva and BD Nexiva Diffusics Closed IV Catheter SystemsBecton Dickinson Infusion Therapy Systems, Inc. K160592SUPERCATH 6Togo Medikit Co., Ltd.

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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