HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit
by Smiths Medical Asd, Inc. 510(k)
Active
510(k) K163172
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK163172 | Date24 May 2017 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DRS
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2850
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent