Cleared Traditional

K193082 - Fountain ValveTip Infusion Catheter

K193082 is an FDA 510(k) clearance for Fountain ValveTip Infusion Catheter, manufactured by Merit Medical Systems, Inc.. The device is a Class 2 Cardiovascular device with product code KRA cleared through the Traditional 510(k) pathway after a 276-day FDA review.

K193082 · Merit Medical Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2020
Decision
276d
Days
Class 2
Risk

K193082 is an FDA 510(k) clearance for the Fountain ValveTip Infusion Catheter. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on August 7, 2020 after a review of 276 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1210 - 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 - K193082

510(k) Number K193082 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2019
Decision Date August 07, 2020
Days to Decision 276 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
151d slower than avg
Panel avg: 125d · This submission: 276d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KRA Device Classification - Class 2, Special Controls

Product Code KRA Catheter, Continuous Flush
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1210
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 - KRA Catheter, Continuous Flush

All 149
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K193082.
Rebar Micro Catheter
K210114 · Micro Therapeuatics, Inc. D/B/A Ev3 Neurovascular · Feb 2021
MAGIC Infusion Catheter
K202366 · Balt USA, LLC · Jan 2021
Marathon Flow Directed Micro Catheter
K202318 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Sep 2020
ClariVein IC
K201907 · Merit Medical Systems, Inc. · Aug 2020
TRUSELECT Microcatheter
K201792 · Boston Scientific Corporation · Jul 2020
Bendit2.7 Steerable Microcatheter
K200582 · Bend IT Technologies, Ltd. · Jun 2020