510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K901619Substantially Equivalent

Wex Multi Domain Cardiac System (Hd-3L)

Wex Medical Instrumentation Co., Jamaica NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K901619 is the FDA 510(k) clearance record for WEX MULTI DOMAIN CARDIAC SYSTEM (HD-3L), cleared for Wex Medical Instrumentation Co. on under FDA product code LOS. FDA records list one 510(k) clearance for Wex Medical Instrumentation Co. As of , FDA records show no recalls naming K901619.

Clearance record

Decision date
Received
(517 days to decision)
Product code
LOS
Review panel
Unknown
Applicant
Wex Medical Instrumentation Co. 175-01 Rockaway Blvd., Jamaica NY
Third party review
No

Clearances, product code LOS

Trailing 12 months

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

FDA records show no clearances under product code LOS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LOS, 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