Cleared Traditional

K083794 - MECC SET WITH BIOLINE COATING

K083794 is an FDA 510(k) clearance for MECC SET WITH BIOLINE COATING, manufactured by Maquet Cardiopulmonary, AG. The device is a Class 2 Cardiovascular device with product code KFM cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K083794 · Maquet Cardiopulmonary, AG · Cardiovascular device
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Apr 2009
Decision
120d
Days
Class 2
Risk

K083794 is an FDA 510(k) clearance for the MECC SET WITH BIOLINE COATING. Classified as Pump, Blood, Cardiopulmonary Bypass, Non-roller Type (product code KFM), Class II - Special Controls.

Submitted by Maquet Cardiopulmonary, AG (Hirrlingen, DE). The FDA issued a Cleared decision on April 21, 2009 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4360 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Maquet Cardiopulmonary, AG devices

FDA 510(k) Submission Details - K083794

510(k) Number K083794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2008
Decision Date April 21, 2009
Days to Decision 120 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 125d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KFM Device Classification - Class 2, Special Controls

Product Code KFM Pump, Blood, Cardiopulmonary Bypass, Non-roller Type
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4360
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 - KFM Pump, Blood, Cardiopulmonary Bypass, Non-roller Type

All 66
Devices cleared under the same product code (KFM) and FDA review panel - the closest regulatory comparables to K083794.
IMPELLA CONTROLLER
K093801 · Abiomed, Inc. · Jul 2010
AFFIITY CP CENTRIFUGAL BLOOD PUMP
K100631 · Medtronic, Inc. · Jun 2010
ROTAFLOW CENTRIFUGAL PUMP WITH SOFTLINE COATING, MODEL BO-RF-32 (USA)
K090515 · Maquet Cardiopulmonary, AG · Dec 2009
IMPELLA 5.0 CATHETER FAMILY
K083111 · Abiomed, Inc. · Apr 2009
TERUMO ROCSAFE HYBRID PERFUSION SYSTEM
K082321 · Terumo Cardiovascular Systems Corp. · Feb 2009
ROTA FLOW CENTRIFUGAL PUMP WITH BIOLINE COATING, MODELS BE-RF-32, BEQ-RF-32
K080470 · Maquet Cardiopulmonary, AG · Sep 2008