Cleared Special

K151724 - AngioDynamics Mariner Angiographic Cath...

K151724 is the FDA 510(k) clearance for AngioDynamics Mariner Angiographic Cath... by AngioDynamics, Inc.. It is a Class 2 Cardiovascular device (product code DQO) cleared through the Special 510(k) pathway after a 110-day FDA review.

K151724 · AngioDynamics, Inc. · Cardiovascular device
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Oct 2015
Decision
110d
Days
Class 2
Risk

K151724 is an FDA 510(k) clearance for the AngioDynamics Mariner Angiographic Catheters. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by AngioDynamics, Inc. (Queensburgy, US). The FDA issued a Cleared decision on October 14, 2015 after a review of 110 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all AngioDynamics, Inc. devices

Submission Details

510(k) Number K151724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2015
Decision Date October 14, 2015
Days to Decision 110 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
15d faster than avg
Panel avg: 125d · This submission: 110d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 223
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