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)
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.

View all Cardiacassist, Inc. devices

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 19
Devices cleared under the same product code (DWA) and FDA review panel - the closest regulatory comparables to K061369.
STOCKERT CENTRIFUGAL PUMP PLUS SYSTEM (SCP PLUS), MODELS 60-00-10, 60-00-55
K091008 · Sorin Group Deutschland GmbH · Jul 2009
BIO-CONSOLE 560
K080824 · Medtronic Perfusion Systems · May 2008
BIO-CONSOLE, MODEL 560
K070286 · Medtronic · May 2007
BIO-CONSOLE, MODEL 560
K051303 · Medtronic Perfusion Systems · Jun 2005
STOCKERT SCP RHYTHM
K042374 · Stockert Instrumente GmbH · Sep 2004
BARD ISOFLOW BLOOD PUMP
K971421 · C.R. Bard, Inc. · May 1998