Cleared Traditional

K151865 - PremiPatch PTFE Pledget

K151865 is an FDA 510(k) clearance for PremiPatch PTFE Pledget, manufactured by Aesculap, Inc.. The device is a Class 2 Cardiovascular device with product code DXZ cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K151865 · Aesculap, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2015
Decision
111d
Days
Class 2
Risk

K151865 is an FDA 510(k) clearance for the PremiPatch PTFE Pledget. Classified as Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (product code DXZ), Class II - Special Controls.

Submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on October 27, 2015 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3470 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K151865

510(k) Number K151865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 125d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXZ Device Classification - Class 2, Special Controls

Product Code DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3470
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 - DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

All 83
Devices cleared under the same product code (DXZ) and FDA review panel - the closest regulatory comparables to K151865.
PhotoFix Decellularized Bovine Pericardium
K162506 · Cryolife, Inc. · Mar 2017
VascuCel
K162579 · Admedus Regen Pty, Ltd. · Oct 2016
CorMatrix Tyke
K152127 · Cormatrix Cardiovascular, Inc. · Feb 2016
PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair Patch
K142447 · Synovis Life Technologies, Inc. · Jan 2015
VASCU-GUARD Peripheral Vascular Patch
K142461 · Synovis Life Technologies, Inc. · Nov 2014
CORMATRIX ECM FOR VASCULAR REPAIR
K140789 · Cormatrix Cardiovascular, Inc. · Jul 2014
K151865 · PremiPatch PTFE Pledget
Download PDF FDA Summary Aesculap, Inc.