Cleared Traditional

MAXIMA FILTERED HARDSHELL RESERVIOR (K933496) - FDA 510(k) Clearance

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

K933496 · Medtronic Vascular · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1993
Decision
88d
Days
Class 2
Risk

K933496 is an FDA 510(k) clearance for the MAXIMA FILTERED HARDSHELL RESERVIOR. 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 October 15, 1993 after a review of 88 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medtronic Vascular devices

Submission Details

510(k) Number K933496 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1993
Decision Date October 15, 1993
Days to Decision 88 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
37d faster than avg
Panel avg: 125d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 11
Devices cleared under the same product code (DTP) and FDA review panel - the closest regulatory comparables to K933496.
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
MINIMAX (TM) HARDSHELL VENOUS RES W/INTE CARD FILT
K911789 · Medtronic Vascular · Aug 1991
MODEL 5866-46 SLEEVE KIT
K910568 · Medtronic Vascular · Apr 1991
BARD FILTERED CARDIOTOMY RESERVOIR
K902856 · C.R. Bard, Inc. · Sep 1990
MCR4000 & MCR4000F CARDIOTOMY RESERVOIR
K902355 · Medtronic Vascular · Aug 1990