Cleared Traditional

VENOUS RESERVOIR W/CARDIOTOMY FILTER (K915573) - FDA 510(k) Clearance

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

K915573 · Baxter Healthcare Corp · Cardiovascular device
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Dec 1992
Decision
377d
Days
Class 2
Risk

K915573 is an FDA 510(k) clearance for the VENOUS RESERVOIR W/CARDIOTOMY FILTER. Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Irvine, US). The FDA issued a Cleared decision on December 23, 1992 after a review of 377 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K915573 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1991
Decision Date December 23, 1992
Days to Decision 377 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
252d slower than avg
Panel avg: 125d · This submission: 377d
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 K915573.
MAXIMA FORTE HARDSHELL VENOUS RESERVOIR
K961836 · Medtronic Vascular · Nov 1996
VENOUS RESERVIOR/CARDIOTOMY AUTOTRANSFUSION FILTER WITH DURAFLO II HEPARIN TREATMENT
K933713 · Baxter Healthcare Corp · Mar 1994
BARD(R) BLOOD CARDIOPLEGIA HEAT EXCHANGER/TUBE SET
K930299 · C.R. Bard, Inc. · Jun 1993
MVR COLLAPSIBLE VENOUS RESERVOIR BAG
K920774 · Medtronic Vascular · Oct 1992
MINIMAX (TM) COLLAPSIBLE VENOUS RESERVOIR BAG
K911790 · Medtronic Vascular · Aug 1991
SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200
K911876 · Shiley, Inc. · Aug 1991