FDA 510(k)

SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter

Numéro K : K241115 · 2024-11-27

Date de décision2024-11-27

Code produitFOZ

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV 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 2024-11-27 under 510(k) number K241115. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter?

SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter is a medical device that received FDA 510(k) clearance on 2024-11-27. The listed applicant is Spectrum Vascular. The 510(k) number is K241115.

When did SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter receive FDA 510(k) clearance?

SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter received FDA 510(k) clearance on 2024-11-27, under 510(k) number K241115.

Who is the listed applicant for SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV 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 SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter?

The FDA product code for SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter is FOZ.

Essais cliniques associés

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Autres dossiers indiquant Spectrum Vascular en tant que demandeur

K260165Unimpregnated Central Venous Catheter 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

Dispositifs connexes (Code : FOZ)

K260432Ruby Intravascular CatheterVenocare, Inc.K260165Unimpregnated Central Venous CatheterSpectrum Vascular 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.

Source officielle

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