Cleared Traditional

K140192 - CARPENTIER BI-CAVAL FEMORAL CANNULA

K140192 is the FDA 510(k) clearance for CARPENTIER BI-CAVAL FEMORAL CANNULA by Medtronic, Inc.. It is a Class 2 Cardiovascular device (product code DWF) cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K140192 · Medtronic, Inc. · Cardiovascular device
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May 2014
Decision
115d
Days
Class 2
Risk

K140192 is an FDA 510(k) clearance for the CARPENTIER BI-CAVAL FEMORAL CANNULA. 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 22, 2014 after a review of 115 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 K140192 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2014
Decision Date May 22, 2014
Days to Decision 115 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
10d faster than avg
Panel avg: 125d · This submission: 115d
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 148
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