FDA 510(k)

Unimpregnated Central Venous Catheter

K-Number: K260165 · 2026-08-10

Decision Date2026-08-10

Product CodeFOZ

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Unimpregnated Central Venous Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Spectrum Vascular. It received FDA 510(k) clearance on 2026-08-10 under 510(k) number K260165. 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 Unimpregnated Central Venous Catheter?

Unimpregnated Central Venous Catheter is a medical device that received FDA 510(k) clearance on 2026-08-10. The listed applicant is Spectrum Vascular. The 510(k) number is K260165.

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

Unimpregnated Central Venous Catheter received FDA 510(k) clearance on 2026-08-10, under 510(k) number K260165.

Who is the listed applicant for Unimpregnated Central Venous Catheter?

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

What is the FDA product code for Unimpregnated Central Venous Catheter?

The FDA product code for Unimpregnated 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 CatheterTERMINATED NCT02279121ATAPAC Study (TauroLock Activity in Adult Cancer Patients)COMPLETED NCT02798926Polyethylene Bag: a Way of Preventing Hypothermia During Central Venous Catheter Placement in Preterm Neonates?COMPLETED NCT04559334Compassionate-Use of 4% T-EDTA Lock Solution for Central Venous Lines of Pediatric PN PatientsSUSPENDED NCT05050799US Post-Market Surveillance Study of the Surfacer SystemRECRUITING NCT05879835KiteLock 4% EDTA Lock Solution for the Prevention of Occlusions in Children With Intestinal FailureRECRUITING

Other records listing Spectrum Vascular as applicant

K261455Arterial Pressure Monitoring Set/Tray K254278Arterial Pressure Monitoring Set/Tray K252373BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve Technology K250724Intraosseous Infusion Needles K241115SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter

Related Devices (Code: FOZ)

K261041ClearSafe Closed SystemMedSource Labs, LLC K260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLC K253235Introcan 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 K252398SURFLO Hybria Closed System Safety IV CatheterTerumo Medical Products (Hangzhou) Co., Ltd.

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.