Clearance Summary
HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX received FDA 510(k) clearance under submission number K101271, sponsored by Medtronic, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2010-10-13.
- Submission: K101271
- Applicant / Sponsor: Medtronic, Inc.
- Clearance pathway: Special
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5680
- Decision date: 2010-10-13
Classification & Regulation
This clearance is catalogued under FDA product code JOX and 21 CFR 864.5680, within the Hematology review panel as a Class II device.