510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K883852Substantially Equivalent

Catheter, Cardiovascular, Balloon Type

Wb Intl., Inc., Miami FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K883852 is the FDA 510(k) clearance record for CATHETER, CARDIOVASCULAR, BALLOON TYPE, a class II device, cleared for Wb Intl., Inc. on under FDA product code DXE (Catheter, Embolectomy). FDA records list 2 510(k) clearances for Wb Intl., Inc., from to . As of , FDA records show no recalls naming K883852.

Clearance record

Decision date
Received
(450 days to decision)
Product code
DXE Catheter, Embolectomy
Regulation
21 CFR 870.5150
Device class
Class II
Review panel
Cardiovascular
Applicant
Wb Intl., Inc. 12491 SW 130th St., Miami FL
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