Cleared Traditional

K962129 - CONTINUOUS FLUSH DEVICE

K962129 is the FDA 510(k) clearance for CONTINUOUS FLUSH DEVICE by Merit Medical Systems, Inc.. It is a Class 2 Cardiovascular device (product code KRA) cleared through the Traditional 510(k) pathway after a 316-day FDA review.

K962129 · Merit Medical Systems, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Apr 1997
Decision
316d
Days
Class 2
Risk

K962129 is an FDA 510(k) clearance for the CONTINUOUS FLUSH DEVICE. 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 April 15, 1997 after a review of 316 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 K962129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1996
Decision Date April 15, 1997
Days to Decision 316 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
191d slower than avg
Panel avg: 125d · This submission: 316d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 127
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K962129.
TRANSIT/RAPIDTRANSIT/SPEEDSTER/PROWLER INFUSION CATHETER
K972518 · Cordis Neurovascular, Inc. · Nov 1997
FG INFUSION CATHETER
K971306 · Cordis Neurovascular, Inc. · Jul 1997
2.9F CRAGG-MCNAMARA VALVED INFUSION CATHETER
K964868 · Micro Therapeutics, Inc. · May 1997
SPINNAKER
K965189 · Target Therapeutics · Mar 1997
CES INFUSION CATHETER
K965181 · Cordis Neurovascular, Inc. · Mar 1997
INTRAVASCULAR INFUSION DEVICE
K963988 · Boston Scientific Corp · Dec 1996