Cleared Special

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

K250558 · Medtronic, Inc. · Cardiovascular
Mar 2025
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K250558 is an FDA 510(k) clearance for the SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315), a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Medtronic, Inc. (Mounds View, US). The FDA issued a Cleared decision on March 27, 2025, 30 days after receiving the submission on February 25, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K250558 FDA.gov
FDA Decision Cleared SESE
Date Received February 25, 2025
Decision Date March 27, 2025
Days to Decision 30 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQY — Catheter, Percutaneous
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1250

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