Cleared Traditional

K960356 - POSTERIOR ANNULOPLASTY BAND (MODEL 607)

K960356 is an FDA 510(k) clearance for POSTERIOR ANNULOPLASTY BAND (MODEL 607), 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 215-day FDA review.

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

FDA 510(k) Submission Details - K960356

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.

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 49
Devices cleared under the same product code (KRH) and FDA review panel - the closest regulatory comparables to K960356.
DURAN FLEXIBLE ANNULOPLASTY RING MODEL NUMBER H608H
K980534 · The Heart Valve Div. Medtronic Cardiovascular Surg · Apr 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
COSGROVE EDWARDS ANNULOPLASTY SYSTEM, MODEL 4600
K923367 · Baxter Healthcare Corp · Jan 1993
PTI ANNULOPLASTY RING(STERILE)
K905175 · Pioneering Technologies, Inc. · Feb 1992