Cleared Traditional

K100274 - MIAR (MINIMALLY INVASIVE AORTIC ROOT) C...

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

K100274 · Medtronic, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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 202
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K100274.
MEDLINE VESSEL CANNULA
K111147 · Medline Industries, Inc. · Jul 2011
HLS CANNULA NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING
K102532 · Maquet Cardiopulmonary, AG · Feb 2011
EMBOL-X ACCESS DEVICE/ AORTIC CANNULA, EMBOL-X SLIM ACCESSDEVICE/ AORTIC CANNULA, EMBOL-X GLIDE ACCESS DEVICE/ AORTIC CA
K102420 · Edwards Lifesciences, LLC · Oct 2010
PORT ACCESS SYSTEMS ENDODIRECT ARTERIAL CANNULA MODEL ED24 (OLD CODE WAS-DFK24)
K093730 · Edwards Lifesciences, LLC · Jan 2010
HLM TUBING SET WITH SOFTLINE COATING
K090533 · Maquet Cardiopulmonary, AG · Dec 2009
EDWARDS LIFESCIENCES VENOUS RETURN CANNULAE
K092509 · Edwards Lifesciences, LLC · Oct 2009