Clearance Summary
SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7, C146HF7, S146F7, S146HF7 received FDA 510(k) clearance under submission number K001063, sponsored by Baxter Healthcare Corp. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2000-07-07.
- Submission: K001063
- Applicant / Sponsor: Baxter Healthcare Corp
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1240
- Decision date: 2000-07-07
Classification & Regulation
This clearance is catalogued under FDA product code DYG and 21 CFR 870.1240, within the Cardiovascular review panel as a Class II device.