Cleared Traditional

K073324 - MEDTRONIC PROFILE 3D ANNULOPLASTY RING, MODEL 680R (FDA 510(k) Clearance)

K073324 · Medtronic, Inc. · Cardiovascular device
Mar 2008
Decision
107d
Days
Class 2
Risk

K073324 is an FDA 510(k) clearance for the MEDTRONIC PROFILE 3D ANNULOPLASTY RING, MODEL 680R. This device is classified as a Ring, Annuloplasty (Class II - Special Controls, product code KRH).

Submitted by Medtronic, Inc. (Minneapolis, US). The FDA issued a Cleared decision on March 13, 2008, 107 days after receiving the submission on November 27, 2007.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3800.

Submission Details

510(k) Number K073324 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 2007
Decision Date March 13, 2008
Days to Decision 107 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code KRH — Ring, Annuloplasty
Device Class Class II - Special Controls
CFR Regulation 21 CFR 870.3800