Cleared Traditional

K911789 - MINIMAX (TM) HARDSHELL VENOUS RES W/INTE CARD FILT

K911789 is an FDA 510(k) clearance for MINIMAX (TM) HARDSHELL VENOUS RES W/INT..., manufactured by Medtronic Vascular. The device is a Class 2 Cardiovascular device with product code DTP cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K911789 · Medtronic Vascular · Cardiovascular device
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Aug 1991
Decision
120d
Days
Class 2
Risk

K911789 is an FDA 510(k) clearance for the MINIMAX (TM) HARDSHELL VENOUS RES W/INTE CARD FILT. Classified as Defoamer, Cardiopulmonary Bypass (product code DTP), Class II - Special Controls.

Submitted by Medtronic Vascular (Anaheim, US). The FDA issued a Cleared decision on August 20, 1991 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 870.4230 - 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 Vascular devices

FDA 510(k) Submission Details - K911789

510(k) Number K911789 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1991
Decision Date August 20, 1991
Days to Decision 120 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
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.

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 K911789.
SARNS FILTERED VENOUS RESERVIOR MODIFICATION
K941654 · 3M Health Care, Sarns · Jul 1994
MAXIMA FILTERED HARDSHELL RESERVIOR
K933496 · Medtronic Vascular · Oct 1993
SARNS NON-FILTERED VENOUS RESERVOIR
K912915 · 3M Health Care, Ltd. · Sep 1991
MODEL 5866-46 SLEEVE KIT
K910568 · Medtronic Vascular · Apr 1991
COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTER
K902437 · Cobe Laboratories, Inc. · Dec 1990
BARD FILTERED CARDIOTOMY RESERVOIR
K902856 · C.R. Bard, Inc. · Sep 1990