Cleared Special

K991619 - FOUNTAIN Infusion Catheter and Occludin...

K991619 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 Special 510(k) pathway after a 29-day FDA review.

K991619 · Merit Medical Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
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Jun 1999
Decision
29d
Days
Class 2
Risk

K991619 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 June 9, 1999 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5150 - 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 Merit Medical Systems, Inc. devices

Submission Details

510(k) Number K991619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1999
Decision Date June 09, 1999
Days to Decision 29 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
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 K991619.
TRELLIS-8 PERIPHERAL INFUSION SYSTEM
K130904 · Covidien · Oct 2013
SPEEDLYSER INFUSION CATHETER KIT
K033443 · AngioDynamics, Inc. · Nov 2003
FOUNTAIN Infusion Catheter and Occluding Guide Wire
K992231 · Merit Medical Systems, Inc. · Jul 1999
Squirt Fluid Delivery System
K981417 · Merit Medical Systems, Inc. · Jul 1998
FOUNTAIN INFUSION CATHETER AND OCCLUDING GUIDE WIRE
K974067 · Merit Medical Systems, Inc. · Feb 1998
Cordis Endeavor Infusion Catheter
K972110 · Cordis Corp. · Aug 1997