K173483 is an FDA 510(k) clearance for the Pure Flow External Counter-Pulsation Device. This device is classified as a Device, Counter-pulsating, External (Class II - Special Controls, product code DRN).
Submitted by Xtreem Pulse, LLC (New York, US). The FDA issued a Cleared decision on May 30, 2018, 198 days after receiving the submission on November 13, 2017.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5225.
| 510(k) Number | K173483 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 2017 |
| Decision Date | May 30, 2018 |
| Days to Decision | 198 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DRN - Device, Counter-pulsating, External |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5225 |