510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K770569Substantially Equivalent

Catheter, Embolectomy, Umi

Universal Medical Instrument Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K770569 is the FDA 510(k) clearance record for CATHETER, EMBOLECTOMY, UMI, a class II device, cleared for Universal Medical Instrument Corp. on under FDA product code DXE (Catheter, Embolectomy). FDA records list 21 510(k) clearances for Universal Medical Instrument Corp., from to . As of , FDA records show no recalls naming K770569.

Clearance record

Decision date
Received
(11 days to decision)
Product code
DXE Catheter, Embolectomy
Regulation
21 CFR 870.5150
Device class
Class II
Review panel
Cardiovascular
Applicant
Universal Medical Instrument Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DXE

Trailing 12 months

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

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