Cleared Traditional

Supreme and Response Electrophysiology Catheters

K161272 · Surgical Instrument Service and Savings, Inc. · Cardiovascular
May 2017
Decision
378d
Days
Class 2
Risk

About This 510(k) Submission

K161272 is an FDA 510(k) clearance for the Supreme and Response Electrophysiology Catheters, 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 18, 2017, 378 days after receiving the submission on May 5, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1220.

Submission Details

510(k) Number K161272 FDA.gov
FDA Decision Cleared SESE
Date Received May 05, 2016
Decision Date May 18, 2017
Days to Decision 378 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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