Heyer-Schulte Afterloading Catheter
FDA 510(k) K832738 · American Heyer Schulte
510(k) numberK832738
Submission
- Device name
- Heyer-Schulte Afterloading Catheter
- Applicant
- American Heyer Schulte
Mchenry, IL, US - Received
- August 12, 1983
- Decision date
- September 29, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Heyer-Schulte Afterloading Catheter cleared by the FDA?
Heyer-Schulte Afterloading Catheter (K832738) received a 510(k) decision of Substantially Equivalent on September 29, 1983, 48 days after the submission was received.
What is the product code of K832738?
The FDA product code is IWJ – System, Applicator, Radionuclide, Manual, a Class I (low risk) device regulated under 21 CFR 892.5650.