Cleared Traditional

K983791 - PERIPHERAL RETROGRADE CARDIAPLEGIA CANNULA

K983791 is the FDA 510(k) clearance for PERIPHERAL RETROGRADE CARDIAPLEGIA CANNULA by Edwards Lifesciences Research Medical. It is a Class 2 Cardiovascular device (product code DWF) cleared through the Traditional 510(k) pathway after a 227-day FDA review.

K983791 · Edwards Lifesciences Research Medical · Cardiovascular device
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Jun 1999
Decision
227d
Days
Class 2
Risk

K983791 is an FDA 510(k) clearance for the PERIPHERAL RETROGRADE CARDIAPLEGIA CANNULA. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Edwards Lifesciences Research Medical (Midvale, US). The FDA issued a Cleared decision on June 11, 1999 after a review of 227 days - an extended review 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: 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 Edwards Lifesciences Research Medical devices

Submission Details

510(k) Number K983791 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1998
Decision Date June 11, 1999
Days to Decision 227 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
102d slower than avg
Panel avg: 125d · This submission: 227d
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 230
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K983791.
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CALIFORNIA MEDICAL LABORATORIES INC. MALLEABLE VENT CATHETER
K981601 · Sorin Group Italia S.R.L. · Jul 1998
QUEST VESSEL CATHETER
K971928 · Quest Medical, Inc. · Nov 1997
CARDIOPLEGIA ADAPTERS, VESSEL CANULAE, AND AORTIC ROOT CANNULAE
K972503 · Sorin Group Italia S.R.L. · Aug 1997