Cleared Traditional

VASCU-GUARD Peripheral Vascular Patch

K142461 · Synovis Life Technologies, Inc. · Cardiovascular
Nov 2014
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K142461 is an FDA 510(k) clearance for the VASCU-GUARD Peripheral Vascular 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 November 25, 2014, 84 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 K142461 FDA.gov
FDA Decision Cleared SESE
Date Received September 02, 2014
Decision Date November 25, 2014
Days to Decision 84 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

Similar Devices — DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

All 89
PeriBeam? Pericardial Membrane
K240775 · Tamabio · Apr 2025
Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch
K200955 · Vascutek, Ltd. · Jul 2020
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
PremiPatch PTFE Pledget
K151865 · Aesculap, Inc. · Oct 2015