Cleared Traditional

LILLIPUP PMP, LILLIPUT PMP INTEGRATED

K151713 · Sorin Group Italia S.R.L. · Cardiovascular
Nov 2015
Decision
134d
Days
Class 2
Risk

About This 510(k) Submission

K151713 is an FDA 510(k) clearance for the LILLIPUP PMP, LILLIPUT PMP INTEGRATED, a Oxygenator, Cardiopulmonary Bypass (Class II — Special Controls, product code DTZ), submitted by Sorin Group Italia S.R.L. (Mirandola, IT). The FDA issued a Cleared decision on November 6, 2015, 134 days after receiving the submission on June 25, 2015. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4350.

Submission Details

510(k) Number K151713 FDA.gov
FDA Decision Cleared SESE
Date Received June 25, 2015
Decision Date November 06, 2015
Days to Decision 134 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DTZ — Oxygenator, Cardiopulmonary Bypass
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4350

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