510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K082139Substantially Equivalent

Edwards Bovine Pericardial Patch, Model 4700

Edwards Lifesciences LLC, Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K082139 is the FDA 510(k) clearance record for EDWARDS BOVINE PERICARDIAL PATCH, MODEL 4700, a class II device, cleared for Edwards Lifesciences, LLC on under FDA product code DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene). FDA records list 165 510(k) clearances for Edwards Lifesciences, LLC, from to . As of , FDA records show no recalls naming K082139.

Clearance record

Decision date
Received
(86 days to decision)
Product code
DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Regulation
21 CFR 870.3470
Device class
Class II
Review panel
Cardiovascular
Applicant
Edwards Lifesciences, LLC One Edwards Way, Irvine CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DXZ

Trailing 12 months

FDA records hold no clearances under product code DXZ in the trailing twelve months.

FDA records show no clearances under product code DXZ in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DXZ, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260