510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K801322Substantially Equivalent

Medi-Trace Disp. Lines for Physio. Press

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

K801322 is the FDA 510(k) clearance record for MEDI-TRACE DISP. LINES FOR PHYSIO. PRESS, a class II device, cleared for Graphic Controls Corp. on under FDA product code DQO (Catheter, Intravascular, Diagnostic). FDA records list 55 510(k) clearances for Graphic Controls Corp., from to . As of , FDA records show no recalls naming K801322.

Clearance record

Decision date
Received
(25 days to decision)
Product code
DQO Catheter, Intravascular, Diagnostic
Regulation
21 CFR 870.1200
Device class
Class II
Review panel
Cardiovascular
Applicant
Graphic Controls Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DQO

Trailing 12 months
3 clearances under product code DQO in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DQO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20261
June 20261
July 20260
August 20260
September 20260
October 20260