Submission Details
| 510(k) Number | K172458 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 14, 2017 |
| Decision Date | November 09, 2017 |
| Days to Decision | 87 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
Nov 2017
Decision
87d
Days
Class 2
Risk
About This 510(k) Submission
K172458 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 November 9, 2017, 87 days after receiving the submission on August 14, 2017. 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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