Cleared Traditional

K980534 - DURAN FLEXIBLE ANNULOPLASTY RING MODEL NUMBER H608H (FDA 510(k) Clearance)

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

K980534 · The Heart Valve Div. Medtronic Cardiovascular Surg · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Apr 1998
Decision
78d
Days
Class 2
Risk

K980534 is an FDA 510(k) clearance for the DURAN FLEXIBLE ANNULOPLASTY RING MODEL NUMBER H608H. Classified as Ring, Annuloplasty (product code KRH), Class II - Special Controls.

Submitted by The Heart Valve Div. Medtronic Cardiovascular Surg (Irvine, US). The FDA issued a Cleared decision on April 30, 1998 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3800 - 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 The Heart Valve Div. Medtronic Cardiovascular Surg devices

Submission Details

510(k) Number K980534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1998
Decision Date April 30, 1998
Days to Decision 78 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
47d faster than avg
Panel avg: 125d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KRH Ring, Annuloplasty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3800
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 - KRH Ring, Annuloplasty

All 73
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