Cleared Traditional

K100274 - MIAR (MINIMALLY INVASIVE AORTIC ROOT) CANNULA WITH FLOW-GUARD, MODELS 11012L AND 11014L

K100274 is an FDA 510(k) clearance for MIAR (MINIMALLY INVASIVE AORTIC ROOT) C..., manufactured by Medtronic, Inc.. The device is a Class 2 Cardiovascular device with product code DWF cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K100274 · Medtronic, Inc. · Cardiovascular device
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May 2010
Decision
101d
Days
Class 2
Risk

K100274 is an FDA 510(k) clearance for the MIAR (MINIMALLY INVASIVE AORTIC ROOT) CANNULA WITH FLOW-GUARD, MODELS 11012L .... Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Medtronic, Inc. (Minneapolis, US). The FDA issued a Cleared decision on May 10, 2010 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4210 - 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 Medtronic, Inc. devices

FDA 510(k) Submission Details - K100274

510(k) Number K100274 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2010
Decision Date May 10, 2010
Days to Decision 101 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
24d faster than avg
Panel avg: 125d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWF Device Classification - Class 2, Special Controls

Product Code DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4210
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 - DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

All 322
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