Cleared Traditional

K070488 - MICARDIA ANNULOPLASTY BAND DR

K070488 is an FDA 510(k) clearance for MICARDIA ANNULOPLASTY BAND DR, manufactured by Micardia Corporation. The device is a Class 2 Cardiovascular device with product code KRH cleared through the Traditional 510(k) pathway after a 562-day FDA review.

K070488 · Micardia Corporation · Cardiovascular device
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Sep 2008
Decision
562d
Days
Class 2
Risk

K070488 is an FDA 510(k) clearance for the MICARDIA ANNULOPLASTY BAND DR. Classified as Ring, Annuloplasty (product code KRH), Class II - Special Controls.

Submitted by Micardia Corporation (Irvine, US). The FDA issued a Cleared decision on September 4, 2008 after a review of 562 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Micardia Corporation devices

FDA 510(k) Submission Details - K070488

510(k) Number K070488 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2007
Decision Date September 04, 2008
Days to Decision 562 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
437d slower than avg
Panel avg: 125d · This submission: 562d
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 50
Devices cleared under the same product code (KRH) and FDA review panel - the closest regulatory comparables to K070488.
DETLOGIX ANNULOPLASTY RING, MODEL: 5100
K083191 · Edwards Lifesciences, LLC · Apr 2009
CARPENTIER- EDWARDS PHYSIO II ANNULOPLASTY, MODEL 5200
K083470 · Edwards Lifesciences, LLC · Jan 2009
ATTUNE ADJUSTABLE FLEXIBLE ANNULOPLASTY RING MODEL AFR
K083835 · St Jude Medical · Jan 2009
MEDTRONIC PROFILE 3D ANNULOPLASTY RING, MODEL 680R
K073324 · Medtronic, Inc. · Mar 2008
CG FUTURE ANNULOPLASTY SYSTEM, MODEL 638R
K061127 · Medtronic Vascular · May 2006
SJM RIGID SADDLE RING MODEL RSAR-(SIZE)
K042734 · St. Jude Medical, Inc. · Dec 2004