Cleared Traditional

Livewire Electrophysiology Catheter

K151617 · Surgical Instrument Service and Savings Inc.(Dba Medline Ren · Cardiovascular
Jan 2016
Decision
221d
Days
Class 2
Risk

About This 510(k) Submission

K151617 is an FDA 510(k) clearance for the Livewire Electrophysiology Catheter, a Catheter, Recording, Electrode, Reprocessed (Class II — Special Controls, product code NLH), submitted by Surgical Instrument Service and Savings Inc.(Dba Medline Ren (Redmond, US). The FDA issued a Cleared decision on January 22, 2016, 221 days after receiving the submission on June 15, 2015. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1220.

Submission Details

510(k) Number K151617 FDA.gov
FDA Decision Cleared SESE
Date Received June 15, 2015
Decision Date January 22, 2016
Days to Decision 221 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code NLH — Catheter, Recording, Electrode, Reprocessed
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1220
Definition Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. (70 Fr 56911, Available At Https://www.govinfo.gov/content/pkg/fr-2005-09-29/pdf/05-19510.pdf).

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