Submission Details
| 510(k) Number | K163172 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 14, 2016 |
| Decision Date | May 24, 2017 |
| Days to Decision | 191 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit
May 2017
Decision
191d
Days
Class 2
Risk
About This 510(k) Submission
K163172 is an FDA 510(k) clearance for the HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit, a Transducer, Blood-pressure, Extravascular (Class II — Special Controls, product code DRS), submitted by Smiths Medical Asd, Inc. (Plymouth, US). The FDA issued a Cleared decision on May 24, 2017, 191 days after receiving the submission on November 14, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2850.
Device Classification
| Product Code | DRS — Transducer, Blood-pressure, Extravascular |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.2850 |
Manufacturer
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