510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K843580Substantially Equivalent

Medi-Trace Transduc Phys Pressure Monito

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

K843580 is the FDA 510(k) clearance record for MEDI-TRACE TRANSDUC PHYS PRESSURE MONITO, a class II device, cleared for Graphic Controls Corp. on under FDA product code DRS (Transducer, Blood-Pressure, Extravascular). FDA records list 55 510(k) clearances for Graphic Controls Corp., from to . As of , FDA records show no recalls naming K843580.

Clearance record

Decision date
Received
(259 days to decision)
Product code
DRS Transducer, Blood-Pressure, Extravascular
Regulation
21 CFR 870.2850
Device class
Class II
Review panel
Cardiovascular
Applicant
Graphic Controls Corp. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code DRS

Trailing 12 months
1 clearance under product code DRS in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DRS, 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 20261
October 20260