Cleared Traditional

K911790 - MINIMAX (TM) COLLAPSIBLE VENOUS RESERVO...

K911790 is the FDA 510(k) clearance for MINIMAX (TM) COLLAPSIBLE VENOUS RESERVO... by Medtronic Vascular. It is a Class 2 Cardiovascular device (product code DTN) cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K911790 · Medtronic Vascular · Cardiovascular device
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Aug 1991
Decision
112d
Days
Class 2
Risk

K911790 is an FDA 510(k) clearance for the MINIMAX (TM) COLLAPSIBLE VENOUS RESERVOIR BAG. Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by Medtronic Vascular (Anaheim, US). The FDA issued a Cleared decision on August 12, 1991 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 870.4400 - 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

Submission Details

510(k) Number K911790 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1991
Decision Date August 12, 1991
Days to Decision 112 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
13d faster than avg
Panel avg: 125d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 128
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K911790.
AUTOTRANSFUSION BLOOD COLLECTION RESERVOIR
K915737 · Electromedics, Inc. · Sep 1992
BLOOD CARDIOPLEGIA HEAT EXCHANGER, MODEL #HE-30
K913956 · Bentley Laboratories, Inc. · Jan 1992
VENOUS RESERVOIR BAG MODEL NO. BMR-250(TM)
K913692 · Bentley Laboratories, Inc. · Nov 1991
SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200
K911876 · Shiley, Inc. · Aug 1991
COBE ICU CONVERSION KIT
K902631 · Cobe Laboratories, Inc. · Dec 1990
INTERSEPT 1375 VENOUS RESERVOIR
K903632 · Medtronic Vascular · Dec 1990