Cleared Special

CV PERI-GUARD AND VASCU-GUARD

K983602 · Bio-Vascular, Inc. · Cardiovascular
Nov 1998
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K983602 is an FDA 510(k) clearance for the CV PERI-GUARD AND VASCU-GUARD, a Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (Class II — Special Controls, product code DXZ), submitted by Bio-Vascular, Inc. (St. Paul, US). The FDA issued a Cleared decision on November 12, 1998, 30 days after receiving the submission on October 13, 1998. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3470.

Submission Details

510(k) Number K983602 FDA.gov
FDA Decision Cleared SESE
Date Received October 13, 1998
Decision Date November 12, 1998
Days to Decision 30 days
Submission Type Special
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