Cleared Traditional

K933713 - VENOUS RESERVIOR/CARDIOTOMY AUTOTRANSFUSION FILTER WITH DURAFLO II HEPARIN TREATMENT

K933713 is an FDA 510(k) clearance for VENOUS RESERVIOR/CARDIOTOMY AUTOTRANSFU..., manufactured by Baxter Healthcare Corp. The device is a Class 2 Cardiovascular device with product code DTN cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K933713 · Baxter Healthcare Corp · Cardiovascular device
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Mar 1994
Decision
214d
Days
Class 2
Risk

K933713 is an FDA 510(k) clearance for the VENOUS RESERVIOR/CARDIOTOMY AUTOTRANSFUSION FILTER WITH DURAFLO II HEPARIN TR.... 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 March 1, 1994 after a review of 214 days - an extended review cycle.

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 Baxter Healthcare Corp devices

FDA 510(k) Submission Details - K933713

510(k) Number K933713 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1993
Decision Date March 01, 1994
Days to Decision 214 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
89d slower than avg
Panel avg: 125d · This submission: 214d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTN Device Classification - Class 2, Special Controls

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 148
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K933713.
MAXIMA FORTE HARDSHELL VENOUS RESERVOIR
K961836 · Medtronic Vascular · Nov 1996
BIOCOR 200 HARDSHELL VENOUS RESERVIOR
K953821 · Minntech Corp. · Mar 1996
SOFT VENOUS RESERVOIR
K955046 · Gish Biomedical, Inc. · Jan 1996
ATR-2900DF (WITH DEPTH FILTER)/CAP-35DF (WITH DEPTH FILTER)
K936286 · Gish Biomedical, Inc. · Feb 1994
EL2-SERIES BLOOD COLLECTION REERVOIR
K930154 · Electromedics, Inc. · Jul 1993
BARD(R) BLOOD CARDIOPLEGIA HEAT EXCHANGER/TUBE SET
K930299 · C.R. Bard, Inc. · Jun 1993