FDA 510(k)

MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV Catheter

N.º K: K260539 · 2026-07-09

Fecha de decisión2026-07-09

Código de productoFOZ

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV Catheter is the device name listed in this FDA 510(k) record. The listed applicant is MedSource Labs, LLC. It received FDA 510(k) clearance on 2026-07-09 under 510(k) number K260539. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV Catheter?

MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV Catheter is a medical device that received FDA 510(k) clearance on 2026-07-09. The listed applicant is MedSource Labs, LLC. The 510(k) number is K260539.

When did MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV Catheter receive FDA 510(k) clearance?

MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV Catheter received FDA 510(k) clearance on 2026-07-09, under 510(k) number K260539.

Who is the listed applicant for MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV Catheter?

The FDA 510(k) record lists MedSource Labs, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV Catheter?

The FDA product code for MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV Catheter is FOZ.

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Otros registros que enlistan a MedSource Labs, LLC como solicitante

K261041ClearSafe Closed System

Dispositivos relacionados (Código: FOZ)

K260432Ruby Intravascular CatheterVenocare, Inc.K260165Unimpregnated Central Venous CatheterSpectrum Vascular K261041ClearSafe Closed SystemMedSource 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

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