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FDA 510(k)

SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315)

K-Number: K250558 · 2025-03-27

ApplicantMedtronic, Inc.
Decision Date2025-03-27
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315) is a medical device manufactured by Medtronic, Inc.. It received FDA 510(k) clearance on 2025-03-27 under approval number K250558. 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 (C304); C315 Delivery System (C315)?

SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315) is a medical device that received FDA 510(k) clearance on 2025-03-27. It is manufactured by Medtronic, Inc.. The 510(k) number is K250558.

When was SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315) approved by the FDA?

SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315) received FDA 510(k) clearance on 2025-03-27, under approval number K250558.

What company makes SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315)?

SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315) is manufactured by Medtronic, Inc..

What is the FDA product code for SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315)?

The FDA product code for SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315) is DQY.

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Related Devices (Code: 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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