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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 a medical device manufactured by Medtronic, Inc.. It received FDA 510(k) clearance on 2019-03-15 under approval 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. It is manufactured by Medtronic, Inc.. The 510(k) number is K183493.

When was SelectSite C304-HIS Deflectable Catheter System approved by the FDA?

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

What company makes SelectSite C304-HIS Deflectable Catheter System?

SelectSite C304-HIS Deflectable Catheter System is manufactured by Medtronic, Inc..

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

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