Clearance Summary
MODIFIED PVA-PLUS FOAM EMBOLIZATION PARTICLES AND MAXISTAT AND MICROSTAT PVA FOAM EMBOLIZATION PARTICLES received FDA 510(k) clearance under submission number K053548, sponsored by Protein Polymer Technologies, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2006-01-30.
- Submission: K053548
- Applicant / Sponsor: Protein Polymer Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5950
- Decision date: 2006-01-30
Classification & Regulation
This clearance is catalogued under FDA product code HCG and 21 CFR 882.5950, within the Neurology review panel as a Class II device.