Clearance Summary
OSCOR PACE 203/PACE 203H DUAL-CHAMBER TEMPORARY PACEMAKER, ST. JUDE MEDICAL, MODEL 3085 DUAL-CHAMBER EXTERNAL PULSE GENE received FDA 510(k) clearance under submission number K020896, sponsored by Osypka Medical, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2002-06-14.
- Submission: K020896
- Applicant / Sponsor: Osypka Medical, Inc.
- Clearance pathway: Abbreviated
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3600
- Decision date: 2002-06-14
Classification & Regulation
This clearance is catalogued under FDA product code DTE and 21 CFR 870.3600, within the Cardiovascular review panel as a Class II device.