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FDA 510(k)

Supreme and Response Electrophysiology Catheters

K-Number: K161272 · 2017-05-18

ApplicantSurgical Instrument Service and Savings, Inc.
Decision Date2017-05-18
Product CodeNLH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Supreme and Response Electrophysiology Catheters is a medical device manufactured by Surgical Instrument Service and Savings, Inc.. It received FDA 510(k) clearance on 2017-05-18 under approval number K161272. The device is classified under product code NLH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Supreme and Response Electrophysiology Catheters?

Supreme and Response Electrophysiology Catheters is a medical device that received FDA 510(k) clearance on 2017-05-18. It is manufactured by Surgical Instrument Service and Savings, Inc.. The 510(k) number is K161272.

When was Supreme and Response Electrophysiology Catheters approved by the FDA?

Supreme and Response Electrophysiology Catheters received FDA 510(k) clearance on 2017-05-18, under approval number K161272.

What company makes Supreme and Response Electrophysiology Catheters?

Supreme and Response Electrophysiology Catheters is manufactured by Surgical Instrument Service and Savings, Inc..

What is the FDA product code for Supreme and Response Electrophysiology Catheters?

The FDA product code for Supreme and Response Electrophysiology Catheters is NLH.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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