Cleared Traditional

K974067 - FOUNTAIN INFUSION CATHETER AND OCCLUDING GUIDE WIRE

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

K974067 · Merit Medical Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K974067

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.

QEY Device Classification - Class 2, Special Controls

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 57
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
K991619 · Merit Medical Systems, Inc. · Jun 1999
Squirt Fluid Delivery System
K981417 · Merit Medical Systems, Inc. · Jul 1998
KAPLAN-SIMPSON INFUSASLEEVE II
K980957 · Localmed, Inc. · Jun 1998
INFUSASLEEVE IIA (IS-2A)
K972175 · Localmed, Inc. · Aug 1997
Cordis Endeavor Infusion Catheter
K972110 · Cordis Corp. · Aug 1997
Cordis Endeavor Infusion Catheter
K970842 · Cordis Corp. · May 1997