510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K820702Substantially Equivalent

Il 7F Flow Director Thermal Dilu. Cath

Instrumentation Laboratory Co., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K820702 is the FDA 510(k) clearance record for IL 7F FLOW DIRECTOR THERMAL DILU. CATH, a class II device, cleared for Instrumentation Laboratory CO on under FDA product code DYG (Catheter, Flow Directed). FDA records list 327 510(k) clearances for Instrumentation Laboratory CO, from to . As of , FDA records show no recalls naming K820702.

Clearance record

Decision date
Received
(37 days to decision)
Product code
DYG Catheter, Flow Directed
Regulation
21 CFR 870.1240
Device class
Class II
Review panel
Cardiovascular
Applicant
Instrumentation Laboratory CO 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