510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K802338Substantially Equivalent

Torque Control Balloon Catheter

Cordis US Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K802338 is the FDA 510(k) clearance record for TORQUE CONTROL BALLOON CATHETER, a class II device, cleared for Cordis Corp. on under FDA product code DYG (Catheter, Flow Directed). FDA records list 332 510(k) clearances for Cordis US Corp., from to . As of , FDA records show no recalls naming K802338.

Clearance record

Decision date
Received
(14 days to decision)
Product code
DYG Catheter, Flow Directed
Regulation
21 CFR 870.1240
Device class
Class II
Review panel
Cardiovascular
Applicant
Cordis Corp. 803 N. Front St. Suite 3, Mchenry IL
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