Cleared Traditional

K913915 - BARD(R) WILLIAM HARVEY(R) MACRO FILT CARDIO RESERV

K913915 is an FDA 510(k) clearance for BARD WILLIAM HARVEY MACRO FILT CARDIO R..., manufactured by Bard Cardiosurgery Div. The device is a Class 2 Cardiovascular device with product code DTN cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K913915 · Bard Cardiosurgery Div · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jan 1992
Decision
140d
Days
Class 2
Risk

K913915 is an FDA 510(k) clearance for the BARD(R) WILLIAM HARVEY(R) MACRO FILT CARDIO RESERV. Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by Bard Cardiosurgery Div (Tewksbury, US). The FDA issued a Cleared decision on January 21, 1992 after a review of 140 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 Bard Cardiosurgery Div devices

FDA 510(k) Submission Details - K913915

510(k) Number K913915 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1991
Decision Date January 21, 1992
Days to Decision 140 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 125d · This submission: 140d
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 149
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K913915.
MVR COLLAPSIBLE VENOUS RESERVOIR BAG
K920774 · Medtronic Vascular · Oct 1992
NEW COBE CARDIOPLEGIA SYSTEM
K920312 · Cobe Cardiovascular, Inc. · Oct 1992
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
MINIMAX (TM) COLLAPSIBLE VENOUS RESERVOIR BAG
K911790 · Medtronic Vascular · Aug 1991