Cleared Traditional

Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors

K182503 · Physio-Control, Inc. · Cardiovascular
Jun 2019
Decision
264d
Days
Class 2
Risk

About This 510(k) Submission

K182503 is an FDA 510(k) clearance for the Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors, a Dc-defibrillator, Low-energy, (including Paddles) (Class II — Special Controls, product code LDD), submitted by Physio-Control, Inc. (Redmond, US). The FDA issued a Cleared decision on June 3, 2019, 264 days after receiving the submission on September 12, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5300.

Submission Details

510(k) Number K182503 FDA.gov
FDA Decision Cleared SESE
Date Received September 12, 2018
Decision Date June 03, 2019
Days to Decision 264 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code LDD — Dc-defibrillator, Low-energy, (including Paddles)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.5300

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