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
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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.

View all Aesculap, Inc. devices

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 50
Devices cleared under the same product code (DXZ) and FDA review panel - the closest regulatory comparables to K151865.
PeriBeam® Pericardial Membrane
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ALBOSURE POLYESTER VASCULAR PATCH
K101740 · LeMaitre Vascular, Inc. · Sep 2010
EDWARDS BOVINE PERICARDIAL PATCH, MODEL 4700
K082139 · Edwards Lifesciences, LLC · Oct 2008
IVENA VASCULAR PATCH
K060396 · Atrium Medical Corp. · May 2006
PTFE FELTS AND PLEDGETS
K041716 · Boston Scientific Corp · Jul 2004