Cleared Traditional

K893678 - DURAN FLEXIBLE ANNULOPLASTY RING & OBTURATOR H601H (FDA 510(k) Clearance)

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

K893678 · Medtronic Blood Systems, Inc. · Cardiovascular device
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Nov 1989
Decision
195d
Days
Class 2
Risk

K893678 is an FDA 510(k) clearance for the DURAN FLEXIBLE ANNULOPLASTY RING & OBTURATOR H601H. Classified as Ring, Annuloplasty (product code KRH), Class II - Special Controls.

Submitted by Medtronic Blood Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on November 27, 1989 after a review of 195 days - an extended review 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: 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 Medtronic Blood Systems, Inc. devices

Submission Details

510(k) Number K893678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1989
Decision Date November 27, 1989
Days to Decision 195 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 125d · This submission: 195d
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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