Cleared Traditional

RETROGRADE CARDIOPLEGIA CANNULA WITH DURAFLO TREATMENT, MODEL DII-RC-014 (K991170) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K991170 · Edwards Lifesciences Research Medical · Cardiovascular device
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Jul 1999
Decision
86d
Days
Class 2
Risk

K991170 is an FDA 510(k) clearance for the RETROGRADE CARDIOPLEGIA CANNULA WITH DURAFLO TREATMENT, MODEL DII-RC-014. 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 July 2, 1999 after a review of 86 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 Edwards Lifesciences Research Medical devices

Submission Details

510(k) Number K991170 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1999
Decision Date July 02, 1999
Days to Decision 86 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
39d faster than avg
Panel avg: 125d · This submission: 86d
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

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