Cleared Traditional

IV START KIT

K953474 · Medikmark, Inc. · General Hospital
Oct 1995
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K953474 is an FDA 510(k) clearance for the IV START KIT, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Medikmark, Inc. (Buffalo Grove, US). The FDA issued a Cleared decision on October 2, 1995, 70 days after receiving the submission on July 24, 1995. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K953474 FDA.gov
FDA Decision Cleared SESE
Date Received July 24, 1995
Decision Date October 02, 1995
Days to Decision 70 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FPA — Set, Administration, Intravascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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