Cleared Traditional

K140999 - TANDEMHEART VENO-VENOUS CANNULA

K140999 is an FDA 510(k) clearance for TANDEMHEART VENO-VENOUS CANNULA, manufactured by Cardiacassist, Inc.. The device is a Class 2 Cardiovascular device with product code DWF cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K140999 · Cardiacassist, Inc. · Cardiovascular device
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Aug 2014
Decision
110d
Days
Class 2
Risk

K140999 is an FDA 510(k) clearance for the TANDEMHEART VENO-VENOUS CANNULA. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Cardiacassist, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on August 6, 2014 after a review of 110 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 Cardiacassist, Inc. devices

FDA 510(k) Submission Details - K140999

510(k) Number K140999 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2014
Decision Date August 06, 2014
Days to Decision 110 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
15d faster than avg
Panel avg: 125d · This submission: 110d
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 330
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K140999.
Bio-Medicus Adult Cannulae and Introducer
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K142593 · AngioDynamics, Inc. · Nov 2014
DLP SILICONE CORONARY ARTERY OSTIAL CANNULAE
K141951 · Medtronic, Inc. · Aug 2014
CARPENTIER BI-CAVAL FEMORAL CANNULA
K140192 · Medtronic, Inc. · May 2014
MC2 TWO-STAGE VENOUS CANNULA, OVAL MC2 TWO-STAGE VENOUS CANNULA, THIN WALL TWO-STAGE VENOUS CANNULA, MC2X THREE-STAGE VE
K140165 · Medtronic, Inc. · May 2014
ANGIOVAC CANNULA
K133445 · Vortex Medical, Inc. · Mar 2014