The following data is part of a premarket notification filed by Curatia Medical Co. with the FDA for Extesia Introducer Sheath Set.
| Device ID | K220604 |
| 510k Number | K220604 |
| Device Name: | EXTesia Introducer Sheath Set |
| Classification | Introducer, Catheter |
| Applicant | Curatia Medical Co. 830 Stewart Dr. Sunnyvale, CA 94085 |
| Contact | Jessica Chiu |
| Correspondent | Breanne Butler Prime Path Medtech 1321 Upland Dr. Suite 6792 Houston, TX 77043 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-02 |
| Decision Date | 2022-04-27 |