Cleared Traditional

MINIMAX (TM) COLLAPSIBLE VENOUS RESERVOIR BAG (K911790) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K911790 · Medtronic Vascular · Cardiovascular device

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

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 46

Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K911790.

BARD(R) BLOOD CARDIOPLEGIA HEAT EXCHANGER/TUBE SET

K930299 · C.R. Bard, Inc. · Jun 1993

VENOUS RESERVOIR W/CARDIOTOMY FILTER

K915573 · Baxter Healthcare Corp · Dec 1992

MVR COLLAPSIBLE VENOUS RESERVOIR BAG

K920774 · Medtronic Vascular · Oct 1992

SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200

K911876 · Shiley, Inc. · Aug 1991

INTERSEPT 1375 VENOUS RESERVOIR

K903632 · Medtronic Vascular · Dec 1990

SOFTSHELL VENOUS RESERVOIR

K904040 · C.R. Bard, Inc. · Dec 1990

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K911790

Medtronic Vascular

Anaheim, CA · US

NORMA L.LOWE

Regulatory profile

475 submissions 453 cleared

95% clearance rate · Active in Cardiovascular

Data Intelligence Layer

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

Verify on FDA.gov

510k Database

510(k) clearances indexed 175,218

Regulatory data since 1976

FDA monthly sync Active