Cleared Traditional

K082613 - MERIT MICROCATHETER

K082613 is the FDA 510(k) clearance for MERIT MICROCATHETER by Merit Medical Systems, Inc.. It is a Class 2 Cardiovascular device (product code KRA) cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K082613 · Merit Medical Systems, Inc. · Cardiovascular device
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Dec 2008
Decision
113d
Days
Class 2
Risk

K082613 is an FDA 510(k) clearance for the MERIT MICROCATHETER. 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 December 30, 2008 after a review of 113 days - within the typical 510(k) review window.

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

Submission Details

510(k) Number K082613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2008
Decision Date December 30, 2008
Days to Decision 113 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
12d faster than avg
Panel avg: 125d · This submission: 113d
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 108
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K082613.
RENEGADE HI-FLO FATHOM KIT MODEL M001182XXX
K100892 · Boston Scientific Corp · Apr 2010
CROSSCATH SUPPORT CATHTER
K093052 · Cook, Inc. · Dec 2009
ECHELON MICRO CATHETER, MODELS 105-5092-150SA, 145-5092-150SA AND 190-5092-150SA AND SYRINGE ADAPTER ACCESSORY
K090870 · Micro Therapeutics, Inc. · May 2009
FINECROSS MG CORONARY MICRO-GUIDE CATHETER
K082519 · Terumo Medical Corp. · Sep 2008
MIRAFLEX HIGH FLOW MICROCATHETER
K080737 · Cook, Inc. · Aug 2008
CXI SUPPORT CATHETER
K072724 · Cook, Inc. · Nov 2007