Clearance Summary
EQUASHIELD CLOSED SYSTEM DRUG TRANSFER DEVICE (CSTD) received FDA 510(k) clearance under submission number K132899, sponsored by Equashield Medical , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2014-05-13.
- Submission: K132899
- Applicant / Sponsor: Equashield Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 2014-05-13
Classification & Regulation
This clearance is catalogued under FDA product code ONB and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.