Cleared Traditional

PremiPatch PTFE Pledget

K151865 · Aesculap, Inc. · Cardiovascular
Oct 2015
Decision
111d
Days
Class 2
Risk

About This 510(k) Submission

K151865 is an FDA 510(k) clearance for the PremiPatch PTFE Pledget, a Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (Class II — Special Controls, product code DXZ), submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on October 27, 2015, 111 days after receiving the submission on July 8, 2015. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3470.

Submission Details

510(k) Number K151865 FDA.gov
FDA Decision Cleared SESE
Date Received July 08, 2015
Decision Date October 27, 2015
Days to Decision 111 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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