Cleared Traditional

UNIRING - ANNULOPLASTY RING WITH SIZERS

K071281 · Peters Surgical · Cardiovascular
Aug 2007
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K071281 is an FDA 510(k) clearance for the UNIRING - ANNULOPLASTY RING WITH SIZERS, a Ring, Annuloplasty (Class II — Special Controls, product code KRH), submitted by Peters Surgical (Bobigny, FR). The FDA issued a Cleared decision on August 3, 2007, 88 days after receiving the submission on May 7, 2007. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3800.

Submission Details

510(k) Number K071281 FDA.gov
FDA Decision Cleared SESE
Date Received May 07, 2007
Decision Date August 03, 2007
Days to Decision 88 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

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