Cleared Traditional

K941654 - SARNS FILTERED VENOUS RESERVIOR MODIFICATION

K941654 is an FDA 510(k) clearance for SARNS FILTERED VENOUS RESERVIOR MODIFIC..., manufactured by 3M Health Care, Sarns. The device is a Class 2 Cardiovascular device with product code DTP cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K941654 · 3M Health Care, Sarns · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jul 1994
Decision
112d
Days
Class 2
Risk

K941654 is an FDA 510(k) clearance for the SARNS FILTERED VENOUS RESERVIOR MODIFICATION. Classified as Defoamer, Cardiopulmonary Bypass (product code DTP), Class II - Special Controls.

Submitted by 3M Health Care, Sarns (Ann Arbor, US). The FDA issued a Cleared decision on July 26, 1994 after a review of 112 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 3M Health Care, Sarns devices

FDA 510(k) Submission Details - K941654

510(k) Number K941654 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1994
Decision Date July 26, 1994
Days to Decision 112 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 125d · This submission: 112d
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 31
Devices cleared under the same product code (DTP) and FDA review panel - the closest regulatory comparables to K941654.
MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VR
K990514 · C.R. Bard, Inc. · Mar 1999
DIDECO D920, LILLIPUT 1 TWIN RESERVOIR
K984322 · Dideco S.P.A. · Mar 1999
BARD QUANTUM CVR
K962726 · C.R. Bard, Inc. · Oct 1996
MAXIMA FILTERED HARDSHELL RESERVIOR
K933496 · Medtronic Vascular · Oct 1993
SARNS NON-FILTERED VENOUS RESERVOIR
K912915 · 3M Health Care, Ltd. · Sep 1991
MINIMAX (TM) HARDSHELL VENOUS RES W/INTE CARD FILT
K911789 · Medtronic Vascular · Aug 1991