Cleared Traditional

PARADIGM QUICK-SET INFUSION SET

K011071 · Maersk Medical A/S · General Hospital
Jun 2001
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K011071 is an FDA 510(k) clearance for the PARADIGM QUICK-SET INFUSION SET, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Maersk Medical A/S (Northridge, US). The FDA issued a Cleared decision on June 7, 2001, 59 days after receiving the submission on April 9, 2001. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K011071 FDA.gov
FDA Decision Cleared SESE
Date Received April 09, 2001
Decision Date June 07, 2001
Days to Decision 59 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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