Cleared Traditional

Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter

K221067 · Surgical Instrument Service and Savings, Inc. · Cardiovascular
May 2023
Decision
414d
Days
Class 2
Risk

About This 510(k) Submission

K221067 is an FDA 510(k) clearance for the Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter, a Catheter, Recording, Electrode, Reprocessed (Class II — Special Controls, product code NLH), submitted by Surgical Instrument Service and Savings, Inc. (Redmond, US). The FDA issued a Cleared decision on May 31, 2023, 414 days after receiving the submission on April 12, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1220.

Submission Details

510(k) Number K221067 FDA.gov
FDA Decision Cleared SESE
Date Received April 12, 2022
Decision Date May 31, 2023
Days to Decision 414 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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