Cleared Traditional

MEDTRONIC MINIMED COUNTACH INFUSION SET, MODEL 313

K032485 · Medtronic Minimed · General Hospital
Oct 2003
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K032485 is an FDA 510(k) clearance for the MEDTRONIC MINIMED COUNTACH INFUSION SET, MODEL 313, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Medtronic Minimed (Northridge, US). The FDA issued a Cleared decision on October 28, 2003, 77 days after receiving the submission on August 12, 2003. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K032485 FDA.gov
FDA Decision Cleared SESE
Date Received August 12, 2003
Decision Date October 28, 2003
Days to Decision 77 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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