Clearance Summary
ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PACK AND BOTTLE SET, ROCKET IPC DRAINAGE B received FDA 510(k) clearance under submission number K123033, sponsored by Rocket Medical Plc. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2013-02-01.
- Submission: K123033
- Applicant / Sponsor: Rocket Medical Plc
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5050
- Decision date: 2013-02-01
Classification & Regulation
This clearance is catalogued under FDA product code DWM and 21 CFR 870.5050, within the Cardiovascular review panel as a Class II device.