Cleared Special

D100 KIDS; D101 KIDS

K231652 · Sorin Group Italia S.R.L. · Cardiovascular
Nov 2023
Decision
163d
Days
Class 2
Risk

About This 510(k) Submission

K231652 is an FDA 510(k) clearance for the D100 KIDS; D101 KIDS, a Oxygenator, Cardiopulmonary Bypass (Class II — Special Controls, product code DTZ), submitted by Sorin Group Italia S.R.L. (Mirandola (Modena), IT). The FDA issued a Cleared decision on November 16, 2023, 163 days after receiving the submission on June 6, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4350.

Submission Details

510(k) Number K231652 FDA.gov
FDA Decision Cleared SESE
Date Received June 06, 2023
Decision Date November 16, 2023
Days to Decision 163 days
Submission Type Special
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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