Cleared Traditional

K960356 - POSTERIOR ANNULOPLASTY BAND (MODEL 607) (FDA 510(k) Clearance)

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

K960356 · The Heart Valve Div. Medtronic Cardiovascular Surg · Cardiovascular device
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Aug 1996
Decision
215d
Days
Class 2
Risk

K960356 is an FDA 510(k) clearance for the POSTERIOR ANNULOPLASTY BAND (MODEL 607). 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 August 27, 1996 after a review of 215 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 The Heart Valve Div. Medtronic Cardiovascular Surg devices

Submission Details

510(k) Number K960356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received January 25, 1996
Decision Date August 27, 1996
Days to Decision 215 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 125d · This submission: 215d
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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