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FDA 510(k)

Cook® Spectrum® 2 MRC Central Venous Catheter

K-Number: K223648 · 2023-02-03

ApplicantCook Advanced Technologies
Decision Date2023-02-03
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Cook® Spectrum® 2 MRC Central Venous Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Cook Advanced Technologies. It received FDA 510(k) clearance on 2023-02-03 under 510(k) number K223648. 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 Cook® Spectrum® 2 MRC Central Venous Catheter?

Cook® Spectrum® 2 MRC Central Venous Catheter is a medical device that received FDA 510(k) clearance on 2023-02-03. The listed applicant is Cook Advanced Technologies. The 510(k) number is K223648.

When did Cook® Spectrum® 2 MRC Central Venous Catheter receive FDA 510(k) clearance?

Cook® Spectrum® 2 MRC Central Venous Catheter received FDA 510(k) clearance on 2023-02-03, under 510(k) number K223648.

Who is the listed applicant for Cook® Spectrum® 2 MRC Central Venous Catheter?

The FDA 510(k) record lists Cook Advanced Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cook® Spectrum® 2 MRC Central Venous Catheter?

The FDA product code for Cook® Spectrum® 2 MRC 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.

NCT07585188Neonatal Catheter Lock for Infection PreventionNOT_YET_RECRUITINGNCT01154465A 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 SystemRECRUITING

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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