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FDA 510(k)

ACENT™ Central Venous Catheter

K-Number: K193158 · 2020-11-24

ApplicantGlobal Medikit Limited
Decision Date2020-11-24
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ACENT™ Central Venous Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Global Medikit Limited. It received FDA 510(k) clearance on 2020-11-24 under 510(k) number K193158. 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 ACENT™ Central Venous Catheter?

ACENT™ Central Venous Catheter is a medical device that received FDA 510(k) clearance on 2020-11-24. The listed applicant is Global Medikit Limited. The 510(k) number is K193158.

When did ACENT™ Central Venous Catheter receive FDA 510(k) clearance?

ACENT™ Central Venous Catheter received FDA 510(k) clearance on 2020-11-24, under 510(k) number K193158.

Who is the listed applicant for ACENT™ Central Venous Catheter?

The FDA 510(k) record lists Global Medikit Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACENT™ Central Venous Catheter?

The FDA product code for ACENT™ Central Venous Catheter is FOZ.

Related Clinical Trials

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.

NCT01154465A Trial to Study the Influence of Ultrasound Guidance on the Complications of Central CatheterTERMINATEDNCT02279121ATAPAC Study (TauroLock Activity in Adult Cancer Patients)COMPLETEDNCT02798926Polyethylene Bag: a Way of Preventing Hypothermia During Central Venous Catheter Placement in Preterm Neonates?COMPLETEDNCT04559334Compassionate-Use of 4% T-EDTA Lock Solution for Central Venous Lines of Pediatric PN PatientsSUSPENDEDNCT05050799US Post-Market Surveillance Study of the Surfacer SystemRECRUITINGNCT05879835KiteLock 4% EDTA Lock Solution for the Prevention of Occlusions in Children With Intestinal FailureRECRUITING

Other records listing Global Medikit Limited 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.

K212982Medispine - Spinal Needle, Glospine - Spinal Needle

Related Devices (Code: FOZ)

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.

K260165Unimpregnated Central Venous CatheterSpectrum VascularK261041ClearSafe Closed SystemMedSource Labs, LLCK260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLCK253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc.K252137BD Insyte™ IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.K252513Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm ; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm)Poly Medicure Limited

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.

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