Cleared Traditional

K980534 - DURAN FLEXIBLE ANNULOPLASTY RING MODEL NUMBER H608H

K980534 is an FDA 510(k) clearance for DURAN FLEXIBLE ANNULOPLASTY RING MODEL ..., manufactured by The Heart Valve Div. Medtronic Cardiovascular Surg. The device is a Class 2 Cardiovascular device with product code KRH cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K980534 · The Heart Valve Div. Medtronic Cardiovascular Surg · Cardiovascular device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K980534

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
Combination Product No
PCCP Authorized No
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.

KRH Device Classification - Class 2, Special Controls

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 48
Devices cleared under the same product code (KRH) and FDA review panel - the closest regulatory comparables to K980534.
SJM TAILOR ANNULOPLASTY RING, MODEL TARN
K000119 · St. Jude Medical, Inc. · Feb 2000
MEDTRONIC KHONSARI ANNULOPLASTY BAND, MODEL H609M
K984435 · Medtronic Vascular · Jan 1999
CARPENTER-EDWARDS CLASSIC RING WITH DURAFLO TREATMENT MODELS 4425 (MITRAL) AND 4525 (TRICUSPID), CARPENTER-EDWARDS PHYSM
K980487 · Baxter Edwards · Jul 1998
ANNULOFLO SYSTEM
K970375 · Carbomedics, Inc. · Jul 1997
SJM SEGUIN ANNULOPLASTY RING MODEL SAR-M
K961246 · St. Jude Medical, Inc. · Feb 1997
CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING
K926138 · Baxter Healthcare Corp · Jun 1993