K200624 is an FDA 510(k) clearance for the Percutaneous Introducer. This device is classified as a Catheter, Conduction, Anesthetic (Class II - Special Controls, product code BSO).
Submitted by Epimed International, Inc. (Farmers Branch, US). The FDA issued a Cleared decision on April 27, 2020, 48 days after receiving the submission on March 10, 2020.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5120.
| 510(k) Number | K200624 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 10, 2020 |
| Decision Date | April 27, 2020 |
| Days to Decision | 48 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BSO - Catheter, Conduction, Anesthetic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5120 |