Cleared Special

SelectSite C304 Deflectable Catheter System (C304) (K250558) - FDA 510(k) Clearance

Also marketed or referenced as:
C315 Delivery System (C315)

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

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

K250558 is an FDA 510(k) clearance for the SelectSite C304 Deflectable Catheter System (C304). Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Medtronic, Inc. (Mounds View, US). The FDA issued a Cleared decision on March 27, 2025 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medtronic, Inc. devices

Submission Details

510(k) Number K250558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DQY Catheter, Percutaneous

All 344
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K250558.
Amulet™ Steerable Delivery Sheath
K250426 · Abbott Medical · Apr 2025
FlowGuide (FG60F)
K242337 · Imds Operations B.V. · Apr 2025
LiquID .051 LP Guide Catheter Extension
K243691 · Seigla Medical, Inc. · Apr 2025
Seclusion Catheter
K243436 · Basis Medical · Feb 2025
Ventrax™ Delivery System
K242873 · Merit Medical Systems, Inc. · Jan 2025
COREPASS Modular Microcatheter (FLEX)
K242588 · OrbusNeich Medical (Shenzhen) Co., Ltd. · Jan 2025