Clearance Summary
CRAFT DUO-VAC SUCTION UNIT, CRAFT SUCTION UNIT received FDA 510(k) clearance under submission number K972867, sponsored by Rocket Medical Plc. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1997-10-24.
- Submission: K972867
- Applicant / Sponsor: Rocket Medical Plc
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.1850
- Decision date: 1997-10-24
Classification & Regulation
This clearance is catalogued under FDA product code ICX and 21 CFR 864.1850, within the Hematology review panel as a Class I device.