Cleared Traditional

PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair Patch

K142447 · Synovis Life Technologies, Inc. · Cardiovascular
Jan 2015
Decision
127d
Days
Class 2
Risk

About This 510(k) Submission

K142447 is an FDA 510(k) clearance for the PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair Patch, a Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (Class II — Special Controls, product code DXZ), submitted by Synovis Life Technologies, Inc. (St. Paul, US). The FDA issued a Cleared decision on January 7, 2015, 127 days after receiving the submission on September 2, 2014. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3470.

Submission Details

510(k) Number K142447 FDA.gov
FDA Decision Cleared SESE
Date Received September 02, 2014
Decision Date January 07, 2015
Days to Decision 127 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DXZ — Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.3470

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