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FDA 510(k)

SelectSite C304 Deflectable Catheter System, C315 Delivery System

K-Number: K223178 · 2022-11-08

ApplicantMedtronic
Decision Date2022-11-08
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SelectSite C304 Deflectable Catheter System, C315 Delivery System is a medical device manufactured by Medtronic. It received FDA 510(k) clearance on 2022-11-08 under approval number K223178. 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 Deflectable Catheter System, C315 Delivery System?

SelectSite C304 Deflectable Catheter System, C315 Delivery System is a medical device that received FDA 510(k) clearance on 2022-11-08. It is manufactured by Medtronic. The 510(k) number is K223178.

When was SelectSite C304 Deflectable Catheter System, C315 Delivery System approved by the FDA?

SelectSite C304 Deflectable Catheter System, C315 Delivery System received FDA 510(k) clearance on 2022-11-08, under approval number K223178.

What company makes SelectSite C304 Deflectable Catheter System, C315 Delivery System?

SelectSite C304 Deflectable Catheter System, C315 Delivery System is manufactured by Medtronic.

What is the FDA product code for SelectSite C304 Deflectable Catheter System, C315 Delivery System?

The FDA product code for SelectSite C304 Deflectable Catheter System, C315 Delivery 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.

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