510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K832738Substantially Equivalent

Heyer-Schulte Afterloading Catheter

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

K832738 is the FDA 510(k) clearance record for HEYER-SCHULTE AFTERLOADING CATHETER, a class I device, cleared for American Heyer Schulte on under FDA product code IWJ (System, Applicator, Radionuclide, Manual). FDA records list 13 510(k) clearances for American Heyer Schulte, from to . As of , FDA records show no recalls naming K832738.

Clearance record

Decision date
Received
(48 days to decision)
Product code
IWJ System, Applicator, Radionuclide, Manual
Regulation
21 CFR 892.5650
Device class
Class I
Review panel
Radiology
Applicant
American Heyer Schulte 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code IWJ

Trailing 12 months

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

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