Cleared Special

K132166 - VENOUS HARDSHELL CARDIOTOMY RESERVOIR (FDA 510(k) Clearance)

Also includes:
NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHT

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

K132166 · Maquet Cardiopulmonary, AG · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2013
Decision
110d
Days
Class 2
Risk

K132166 is an FDA 510(k) clearance for the VENOUS HARDSHELL CARDIOTOMY RESERVOIR. Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by Maquet Cardiopulmonary, AG (Rastatt De-Bw, DE). The FDA issued a Cleared decision on October 30, 2013 after a review of 110 days - within the typical 510(k) review window.

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. 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 Maquet Cardiopulmonary, AG devices

Submission Details

510(k) Number K132166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2013
Decision Date October 30, 2013
Days to Decision 110 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
15d faster than avg
Panel avg: 125d · This submission: 110d
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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