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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 the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2025-03-27 under 510(k) 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. The listed applicant is Medtronic, Inc.. The 510(k) number is K250558.

When did SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315) receive FDA 510(k) clearance?

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

Who is the listed applicant for SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315)?

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 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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT00271180Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy ProductsRECRUITINGNCT07005232Lead Evaluation for Defibrillation and Reliability Post Approval StudyENROLLING_BY_INVITATION

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Related Devices (Code: DQY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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