The following data is part of a premarket notification filed by Smiths Medical Asd, Inc. with the FDA for Hemodraw Plus Closed Blood Sampling System With Logical Transducer Kit, Hemodraw Plus Closed Blood Sampling System With Transtar Transducer Kit.
| Device ID | K163172 |
| 510k Number | K163172 |
| Device Name: | HemoDraw Plus Closed Blood Sampling System With LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System With Transtar Transducer Kit |
| Classification | Transducer, Blood-pressure, Extravascular |
| Applicant | SMITHS MEDICAL ASD, INC. 6000 NATHAN LANE N Minneapolis, MN 55442 |
| Contact | Bruce Backlund |
| Correspondent | Bruce Backlund SMITHS MEDICAL ASD, INC. 6000 NATHAN LANE N Minneapolis, MN 55442 |
| Product Code | DRS |
| CFR Regulation Number | 870.2850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-14 |
| Decision Date | 2017-05-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 35019517162602 | K163172 | 000 |
| 35019517082108 | K163172 | 000 |
| 35019517082115 | K163172 | 000 |
| 35019517082146 | K163172 | 000 |
| 35019517082177 | K163172 | 000 |
| 35019517082184 | K163172 | 000 |
| 35019517082191 | K163172 | 000 |
| 35019517082412 | K163172 | 000 |
| 35019517082429 | K163172 | 000 |
| 35019517082450 | K163172 | 000 |
| 35019517087547 | K163172 | 000 |
| 35019517082092 | K163172 | 000 |