Clearance Summary
FASTLOCK, MODEL PC175M01, PC175MCE, PC005R01 received FDA 510(k) clearance under submission number K080621, sponsored by European Custom Manufacturing BV. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2008-04-29.
- Submission: K080621
- Applicant / Sponsor: European Custom Manufacturing BV
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2900
- Decision date: 2008-04-29
Classification & Regulation
This clearance is catalogued under FDA product code DSA and 21 CFR 870.2900, within the Cardiovascular review panel as a Class II device.