Cleared Special

K021287 - TRILLIUM AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, MODELS 540T, 541TT (FDA 510(k) Clearance)

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

K021287 · Medtronic Perfusion Systems · Cardiovascular device
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Optimized for regulatory review, auditing and printing
May 2002
Decision
14d
Days
Class 2
Risk

K021287 is an FDA 510(k) clearance for the TRILLIUM AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, MODELS 540T, 541TT. Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by Medtronic Perfusion Systems (Minneapolis, US). The FDA issued a Cleared decision on May 7, 2002 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4400 - 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 Medtronic Perfusion Systems devices

Submission Details

510(k) Number K021287 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2002
Decision Date May 07, 2002
Days to Decision 14 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
111d faster than avg
Panel avg: 125d · This submission: 14d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DTN Reservoir, Blood, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4400
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 - DTN Reservoir, Blood, Cardiopulmonary Bypass

All 168
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