Cleared Traditional

MARIAN INFANT FEEDING TUBE (GUARDIANPICC PERCUTANEOUS CENTRAL VENOUS CATHETER

K050542 · Marian Medical, Inc. · General Hospital
Jul 2005
Decision
146d
Days
Class 2
Risk

About This 510(k) Submission

K050542 is an FDA 510(k) clearance for the MARIAN INFANT FEEDING TUBE (GUARDIANPICC PERCUTANEOUS CENTRAL VENOUS CATHETER, a Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (Class II — Special Controls, product code LJS), submitted by Marian Medical, Inc. (Louisville, US). The FDA issued a Cleared decision on July 26, 2005, 146 days after receiving the submission on March 2, 2005. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5970.

Submission Details

510(k) Number K050542 FDA.gov
FDA Decision Cleared SESE
Date Received March 02, 2005
Decision Date July 26, 2005
Days to Decision 146 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code LJS — Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5970

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