K201695 is an FDA 510(k) clearance for the Patent Hemostasis Band (PH Band). This device is classified as a Clamp, Vascular (Class II - Special Controls, product code DXC).
Submitted by Medical Ingenuities (Wheaton, US). The FDA issued a Cleared decision on October 30, 2020, 130 days after receiving the submission on June 22, 2020.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4450.
| 510(k) Number | K201695 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 22, 2020 |
| Decision Date | October 30, 2020 |
| Days to Decision | 130 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXC - Clamp, Vascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4450 |