Cleared Traditional

K981417 - Squirt Fluid Delivery System

K981417 is the FDA 510(k) clearance for Squirt Fluid Delivery System by Merit Medical Systems, Inc.. It is a Class 2 Cardiovascular device (product code QEY) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K981417 · Merit Medical Systems, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jul 1998
Decision
88d
Days
Class 2
Risk

K981417 is an FDA 510(k) clearance for the Squirt Fluid Delivery System. 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 July 17, 1998 after a review of 88 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Merit Medical Systems, Inc. devices

Submission Details

510(k) Number K981417 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1998
Decision Date July 17, 1998
Days to Decision 88 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
37d faster than avg
Panel avg: 125d · This submission: 88d
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 K981417.
SPEEDLYSER INFUSION CATHETER KIT
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K992231 · Merit Medical Systems, Inc. · Jul 1999
FOUNTAIN Infusion Catheter and Occluding Guide Wire
K991619 · Merit Medical Systems, Inc. · Jun 1999
FOUNTAIN INFUSION CATHETER AND OCCLUDING GUIDE WIRE
K974067 · Merit Medical Systems, Inc. · Feb 1998
Cordis Endeavor Infusion Catheter
K972110 · Cordis Corp. · Aug 1997
Cordis Endeavor Infusion Catheter
K970842 · Cordis Corp. · May 1997