Cleared Special

K152161 - Thoratec CentriMag Return (Arterial) Ca...

K152161 is an FDA 510(k) clearance for Thoratec CentriMag Return (Arterial) Ca..., manufactured by Thoratec Corporation. The device is a Class 2 Cardiovascular device with product code DWF cleared through the Special 510(k) pathway after a 46-day FDA review.

K152161 · Thoratec Corporation · Cardiovascular device
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Sep 2015
Decision
46d
Days
Class 2
Risk

K152161 is an FDA 510(k) clearance for the Thoratec CentriMag Return (Arterial) Cannula Kit. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Thoratec Corporation (Pleasanton, US). The FDA issued a Cleared decision on September 18, 2015 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4210 - 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 devices

FDA 510(k) Submission Details - K152161

510(k) Number K152161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2015
Decision Date September 18, 2015
Days to Decision 46 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 125d · This submission: 46d
Pathway characteristics
Modification to existing cleared device.

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 301
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K152161.
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