Cleared Traditional

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

K241115 · Spectrum Vascular · General Hospital

Nov 2024

Decision

218d

Days

Class 2

Risk

About This 510(k) Submission

K241115 is an FDA 510(k) clearance for the SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter, a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II — Special Controls, product code FOZ), submitted by Spectrum Vascular (White Plains, US). The FDA issued a Cleared decision on November 27, 2024, 218 days after receiving the submission on April 23, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K241115 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 23, 2024
Decision Date	November 27, 2024
Days to Decision	218 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	FOZ — Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5200