510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K864007Substantially Equivalent

Embolectomy/thrombectomy Balloon Catheter

Uresil, LLC, Skokie IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864007 is the FDA 510(k) clearance record for EMBOLECTOMY/THROMBECTOMY BALLOON CATHETER, a class II device, cleared for Uresil Corp. on under FDA product code DXE (Catheter, Embolectomy). FDA records list 49 510(k) clearances for Uresil Corp., from to . As of , FDA records show no recalls naming K864007.

Clearance record

Decision date
Received
(79 days to decision)
Product code
DXE Catheter, Embolectomy
Regulation
21 CFR 870.5150
Device class
Class II
Review panel
Cardiovascular
Applicant
Uresil Corp. 5418 W. Touhy Ave., Skokie 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