Clearance Summary
GRAFTGUARD PRESSURE CONTROLLING SYRINGE received FDA 510(k) clearance under submission number K082725, sponsored by Maquet Cardiovascular, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2008-12-17.
- Submission: K082725
- Applicant / Sponsor: Maquet Cardiovascular, LLC
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4200
- Decision date: 2008-12-17
Classification & Regulation
This clearance is catalogued under FDA product code GBX and 21 CFR 878.4200, within the General, Plastic Surgery review panel as a Class I device.