Clearance Summary
HEYER-SCHULTE AFTERLOADING CATHETER received FDA 510(k) clearance under submission number K832738, sponsored by American Heyer Schulte. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1983-09-29.
- Submission: K832738
- Applicant / Sponsor: American Heyer Schulte
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.5650
- Decision date: 1983-09-29
Classification & Regulation
This clearance is catalogued under FDA product code IWJ and 21 CFR 892.5650, within the Radiology review panel as a Class I device.