Cleared Traditional

K140557 - MIVI 6F GUIDE CATHETER

K140557 is an FDA 510(k) clearance for MIVI 6F GUIDE CATHETER, manufactured by Mivi, LLC. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K140557 · Mivi, LLC · Cardiovascular device
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Sep 2014
Decision
197d
Days
Class 2
Risk

K140557 is an FDA 510(k) clearance for the MIVI 6F GUIDE CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Mivi, LLC (Maple Grove, US). The FDA issued a Cleared decision on September 18, 2014 after a review of 197 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 Mivi, LLC devices

FDA 510(k) Submission Details - K140557

510(k) Number K140557 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2014
Decision Date September 18, 2014
Days to Decision 197 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d slower than avg
Panel avg: 125d · This submission: 197d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQY Device Classification - Class 2, Special Controls

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 653
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K140557.
TURNPIKE CATHETER
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ENVOY DISTAL ACCESS (DA) GUIDING CATHETER, 6F, 95CM & 105CM, STRAIGHT & XB, MPD & XB, MPC & XB
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ENVOY GUIDING CATHETER
K140307 · Codman & Shurtleff, Inc. · Apr 2014
ACUITY PRO LEAD DELIVERY SYSTEM
K132914 · Boston Scientific · Apr 2014