510(k) K201460
K201460 is an FDA 510(k) premarket notification submitted by Shinva Ande Healthcare Apparatus Co., Ltd. for the device "Closed System Transfer Device". The FDA issued a decision of Substantially Equivalent on November 23, 2022. The device falls under product code ONB (Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System), a Class II device regulated under 21 CFR 880.5440. Shinva Ande Healthcare Apparatus Co., Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 23, 2022
- Date Received
- June 2, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
- Device Class
- Class II
- Regulation Number
- 880.5440
- Review Panel
- HO
- Submission Type
Reconstitute and transfer antineoplastic and other hazardous drugs in healthcare setting indicated to reduce exposure of healthcare personnel to chemotherapy agents in healthcare setting.