FDA 510(k)

SelectSite C304-HIS Deflectable Catheter System

K-Number: K183493 · 2019-03-15

Decision Date2019-03-15

Product CodeDQY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

SelectSite C304-HIS Deflectable Catheter System is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2019-03-15 under 510(k) number K183493. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SelectSite C304-HIS Deflectable Catheter System?

SelectSite C304-HIS Deflectable Catheter System is a medical device that received FDA 510(k) clearance on 2019-03-15. The listed applicant is Medtronic, Inc.. The 510(k) number is K183493.

When did SelectSite C304-HIS Deflectable Catheter System receive FDA 510(k) clearance?

SelectSite C304-HIS Deflectable Catheter System received FDA 510(k) clearance on 2019-03-15, under 510(k) number K183493.

Who is the listed applicant for SelectSite C304-HIS Deflectable Catheter System?

The FDA 510(k) record lists Medtronic, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SelectSite C304-HIS Deflectable Catheter System?

The FDA product code for SelectSite C304-HIS Deflectable Catheter System is DQY.

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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.