Cleared Special

CentriMag Acute Circulatory Support System (K191557) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K191557 · Thoratec Corporation (Now Part of Abbott) · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2019
Decision
28d
Days
Class 2
Risk

K191557 is an FDA 510(k) clearance for the CentriMag Acute Circulatory Support System. Classified as Control, Pump Speed, Cardiopulmonary Bypass (product code DWA), Class II - Special Controls.

Submitted by Thoratec Corporation (Now Part of Abbott) (Pleasanton, US). The FDA issued a Cleared decision on July 10, 2019 after a review of 28 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Thoratec Corporation (Now Part of Abbott) devices

Submission Details

510(k) Number K191557 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2019
Decision Date July 10, 2019
Days to Decision 28 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
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 K191557.
INSPIRA ART100
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Anivia SG1000 Pump Console
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Anivia SG1000 Pump Console
K221491 · Apmtd, Inc. · Feb 2023
Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure
K192838 · Spectrum Medical , Ltd. · Apr 2020
CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit
K200306 · Abbott (Formerly Thoratec Corporation) · Mar 2020
BARD ISOFLOW BLOOD PUMP
K971421 · C.R. Bard, Inc. · May 1998