Cleared Traditional

K974067 - FOUNTAIN INFUSION CATHETER AND OCCLUDIN...

K974067 is the FDA 510(k) clearance for FOUNTAIN INFUSION CATHETER AND OCCLUDIN... by Merit Medical Systems, Inc.. It is a Class 2 Cardiovascular device (product code QEY) cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K974067 · Merit Medical Systems, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Feb 1998
Decision
123d
Days
Class 2
Risk

K974067 is an FDA 510(k) clearance for the FOUNTAIN INFUSION CATHETER AND OCCLUDING GUIDE WIRE. Classified as Mechanical Thrombolysis Catheter (product code QEY), Class II - Special Controls.

Submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on February 27, 1998 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5150 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Merit Medical Systems, Inc. devices

Submission Details

510(k) Number K974067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1997
Decision Date February 27, 1998
Days to Decision 123 days
Submission Type Traditional
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
2d faster than avg
Panel avg: 125d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QEY Mechanical Thrombolysis Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5150
Definition To Mechanically Disrupt Thrombus And/or Debris In The Peripheral Vasculature.
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 - QEY Mechanical Thrombolysis Catheter

All 29
Devices cleared under the same product code (QEY) and FDA review panel - the closest regulatory comparables to K974067.
FOUNTAIN Infusion Catheter and Occluding Guide Wire
K992231 · Merit Medical Systems, Inc. · Jul 1999
FOUNTAIN Infusion Catheter and Occluding Guide Wire
K991619 · Merit Medical Systems, Inc. · Jun 1999
Squirt Fluid Delivery System
K981417 · Merit Medical Systems, Inc. · Jul 1998
Cordis Endeavor Infusion Catheter
K972110 · Cordis Corp. · Aug 1997
Cordis Endeavor Infusion Catheter
K970842 · Cordis Corp. · May 1997
Multi Side Hole lnfusion System
K953384 · AngioDynamics, Inc. · Dec 1995