510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K821532Substantially Equivalent

Periguard Pericardial Patch

Genetic Laboratories, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K821532 is the FDA 510(k) clearance record for PERIGUARD PERICARDIAL PATCH, a class II device, cleared for Genetic Laboratories, Inc. on under FDA product code DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene). FDA records list 3 510(k) clearances for Genetic Laboratories, Inc., from to . As of , FDA records show no recalls naming K821532.

Clearance record

Decision date
Received
(87 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
Genetic Laboratories, Inc. 4221 Richmond Rd., NW, Walker MI
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 October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DXZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260