Cleared Traditional

K101186 - AFFINITY VARD SUB-ASSEMBLY FOR CPS (CAR...

K101186 is an FDA 510(k) clearance for AFFINITY VARD SUB-ASSEMBLY FOR CPS (CAR..., manufactured by Medtronic Perfusion Systems. The device is a Class 2 Cardiovascular device with product code DTP cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K101186 · Medtronic Perfusion Systems · Cardiovascular device
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Sep 2010
Decision
128d
Days
Class 2
Risk

K101186 is an FDA 510(k) clearance for the AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HO.... Classified as Defoamer, Cardiopulmonary Bypass (product code DTP), Class II - Special Controls.

Submitted by Medtronic Perfusion Systems (Minneapolis, US). The FDA issued a Cleared decision on September 3, 2010 after a review of 128 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4230 - 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 Medtronic Perfusion Systems devices

FDA 510(k) Submission Details - K101186

510(k) Number K101186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2010
Decision Date September 03, 2010
Days to Decision 128 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
3d slower than avg
Panel avg: 125d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTP Device Classification - Class 2, Special Controls

Product Code DTP Defoamer, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4230
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 - DTP Defoamer, Cardiopulmonary Bypass

All 29
Devices cleared under the same product code (DTP) and FDA review panel - the closest regulatory comparables to K101186.
COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
K004046 · Cobe Cardiovascular, Inc. · Apr 2001
COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
K002591 · Cobe Cardiovascular, Inc. · Sep 2000
MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VR
K990514 · C.R. Bard, Inc. · Mar 1999
BARD QUANTUM CVR
K962726 · C.R. Bard, Inc. · Oct 1996
SARNS FILTERED VENOUS RESERVIOR MODIFICATION
K941654 · 3M Health Care, Sarns · Jul 1994
MAXIMA FILTERED HARDSHELL RESERVIOR
K933496 · Medtronic Vascular · Oct 1993