510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K974914Substantially Equivalent

Shelhigh No-React Pericardial Patches

Shelhigh, Inc., Millburn NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K974914 is the FDA 510(k) clearance record for SHELHIGH NO-REACT PERICARDIAL PATCHES, a class II device, cleared for Shelhigh, Inc. on under FDA product code DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene). FDA records list 8 510(k) clearances for Shelhigh, Inc., from to . As of , FDA records show no recalls naming K974914.

Clearance record

Decision date
Received
(177 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
Shelhigh, Inc. P.O. Box 884, Millburn NJ
510(k) summary
Summary
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