Clearance Summary
TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE received FDA 510(k) clearance under submission number K033858, 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 2004-07-12.
- Submission: K033858
- Applicant / Sponsor: European Custom Manufacturing BV
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3680
- Decision date: 2004-07-12
Classification & Regulation
This clearance is catalogued under FDA product code LDF and 21 CFR 870.3680, within the Cardiovascular review panel as a Class II device.