Cleared Traditional

K930593 - BARD WILLIAM HARVEY AORTIC ROOT CARDIOP...

K930593 is the FDA 510(k) clearance for BARD WILLIAM HARVEY AORTIC ROOT CARDIOP... by C.R. Bard, Inc.. It is a Class 2 Cardiovascular device (product code DWF) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K930593 · C.R. Bard, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
May 1993
Decision
91d
Days
Class 2
Risk

K930593 is an FDA 510(k) clearance for the BARD WILLIAM HARVEY AORTIC ROOT CARDIOPLEGIA CANNU. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Tewksbury, US). The FDA issued a Cleared decision on May 6, 1993 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4210 - 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 C.R. Bard, Inc. devices

Submission Details

510(k) Number K930593 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1993
Decision Date May 06, 1993
Days to Decision 91 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
34d faster than avg
Panel avg: 125d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4210
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 - DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

All 229
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K923483 · C.R. Bard, Inc. · Mar 1993
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K922471 · 3M Health Care, Sarns · Mar 1993
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K922992 · 3M Health Care, Ltd. · Sep 1992