Cleared Traditional

K930620 - BARD WILLIAM HARVEY ARTERIAL STRAIGH CA...

K930620 is the FDA 510(k) clearance for BARD WILLIAM HARVEY ARTERIAL STRAIGH CA... by C.R. Bard, Inc.. It is a Class 2 Cardiovascular device (product code DWF) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K930620 · C.R. Bard, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
May 1993
Decision
88d
Days
Class 2
Risk

K930620 is an FDA 510(k) clearance for the BARD(R) WILLIAM HARVEY(R) ARTERIAL STRAIGH CANNULA. 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 7, 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 870.4210 - 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: 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 C.R. Bard, Inc. devices

Submission Details

510(k) Number K930620 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1993
Decision Date May 07, 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 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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K930684 · C.R. Bard, Inc. · May 1993
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K930593 · C.R. Bard, Inc. · May 1993
BARD WILLIAM HARVEY AORTIC ARCH CANULAE
K923483 · C.R. Bard, Inc. · Mar 1993
SARNS RETROGRADE CANNULA - AUTO INFLATE
K922471 · 3M Health Care, Sarns · Mar 1993