Cleared Special

AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH CARMEDA BIOACTIVE

K123448 · Medtronic, Inc. · Cardiovascular

Dec 2012

Decision

35d

Days

Class 2

Risk

About This 510(k) Submission

K123448 is an FDA 510(k) clearance for the AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH CARMEDA BIOACTIVE, a Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (Class II — Special Controls, product code DTL), submitted by Medtronic, Inc. (Minneapolis, US). The FDA issued a Cleared decision on December 13, 2012, 35 days after receiving the submission on November 8, 2012. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4290.

Submission Details

510(k) Number	K123448 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 08, 2012
Decision Date	December 13, 2012
Days to Decision	35 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	DTL — Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.4290