K172457 is an FDA 510(k) clearance for the Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM. This device is classified as a Flowmeter, Blood, Cardiovascular (Class II - Special Controls, product code DPW).
Submitted by Deltex Medical Limited (Chichester, GB). The FDA issued a Cleared decision on June 28, 2018, 318 days after receiving the submission on August 14, 2017.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2100.
| 510(k) Number | K172457 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 14, 2017 |
| Decision Date | June 28, 2018 |
| Days to Decision | 318 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DPW — Flowmeter, Blood, Cardiovascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2100 |