Clearance Summary
MAVIG ANGIO SHIELD MODELS 6290 & 6272 received FDA 510(k) clearance under submission number K934206, sponsored by F. Walter Hanel GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1993-10-07.
- Submission: K934206
- Applicant / Sponsor: F. Walter Hanel GmbH
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.6500
- Decision date: 1993-10-07
Classification & Regulation
This clearance is catalogued under FDA product code KPY and 21 CFR 892.6500, within the Radiology review panel as a Class I device.