Cleared Traditional

MEDTRONIC MINIMED PARADIGM POLYFIN QR, MODEL MMT 312L AND 312S

K031917 · Medtronic Minimed · General Hospital
Aug 2003
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K031917 is an FDA 510(k) clearance for the MEDTRONIC MINIMED PARADIGM POLYFIN QR, MODEL MMT 312L AND 312S, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Medtronic Minimed (Northridge, US). The FDA issued a Cleared decision on August 19, 2003, 57 days after receiving the submission on June 23, 2003. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K031917 FDA.gov
FDA Decision Cleared SESE
Date Received June 23, 2003
Decision Date August 19, 2003
Days to Decision 57 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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