Cleared Special

K061369 - TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500

K061369 is an FDA 510(k) clearance for TANDEM HEART ESCORT (T.H.E.) CONTROLLER, manufactured by Cardiacassist, Inc.. The device is a Class 2 Cardiovascular device with product code DWA cleared through the Special 510(k) pathway after a 97-day FDA review.

K061369 · Cardiacassist, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
97d
Days
Class 2
Risk

K061369 is an FDA 510(k) clearance for the TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500. Classified as Control, Pump Speed, Cardiopulmonary Bypass (product code DWA), Class II - Special Controls.

Submitted by Cardiacassist, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on August 22, 2006 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4380 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K061369

510(k) Number K061369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2006
Decision Date August 22, 2006
Days to Decision 97 days
Submission Type Special
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
28d faster than avg
Panel avg: 125d · This submission: 97d
Pathway characteristics
Modification to existing cleared device.

DWA Device Classification - Class 2, Special Controls

Product Code DWA Control, Pump Speed, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4380
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 - DWA Control, Pump Speed, Cardiopulmonary Bypass

All 36
Devices cleared under the same product code (DWA) and FDA review panel - the closest regulatory comparables to K061369.
LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE
K081221 · Levitronix, LLC · Jun 2008
BIO-CONSOLE 560
K080824 · Medtronic Perfusion Systems · May 2008
BIO-CONSOLE, MODEL 560
K070286 · Medtronic · May 2007
LEVITRONIX CENTRIMAG PRIMARY CONSOLE
K053630 · Levitronix, LLC · Jan 2006
BIO-CONSOLE, MODEL 560
K051303 · Medtronic Perfusion Systems · Jun 2005
STOCKERT SCP RHYTHM
K042374 · Stockert Instrumente GmbH · Sep 2004
K061369 · TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500
Download PDF FDA Summary Cardiacassist, Inc.