510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K833572Substantially Equivalent

Heparin-Coated Balloon Thermodilut

Critikon Company, LLC, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K833572 is the FDA 510(k) clearance record for HEPARIN-COATED BALLOON THERMODILUT, a class II device, cleared for Critikon Company, LLC on under FDA product code DYG (Catheter, Flow Directed). FDA records list 51 510(k) clearances for Critikon Company, LLC, from to . As of , FDA records show no recalls naming K833572.

Clearance record

Decision date
Received
(110 days to decision)
Product code
DYG Catheter, Flow Directed
Regulation
21 CFR 870.1240
Device class
Class II
Review panel
Cardiovascular
Applicant
Critikon Company, LLC 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code DYG

Trailing 12 months

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

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