510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K823790Substantially Equivalent

Ventricular Access System

American Heyer Schulte, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K823790 is the FDA 510(k) clearance record for VENTRICULAR ACCESS SYSTEM, a class II device, cleared for American Heyer Schulte on under FDA product code LKG (Port & Catheter, Implanted, Subcutaneous, Intraventricular). FDA records list 13 510(k) clearances for American Heyer Schulte, from to . As of , FDA records show no recalls naming K823790.

Clearance record

Decision date
Received
(133 days to decision)
Product code
LKG Port & Catheter, Implanted, Subcutaneous, Intraventricular
Regulation
21 CFR 882.5550
Device class
Class II
Review panel
Neurology
Applicant
American Heyer Schulte 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code LKG

Trailing 12 months

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

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