The following data is part of a premarket notification filed by Talon Surgical with the FDA for Cardiocurve Steerable Sheath.
| Device ID | K210185 |
| 510k Number | K210185 |
| Device Name: | CardioCurve Steerable Sheath |
| Classification | Introducer, Catheter |
| Applicant | Talon Surgical 6030 West Harold Gatty Drive Salt Lake City, UT 84116 |
| Contact | Jay Muse |
| Correspondent | Jay Muse Talon Surgical 6030 West Harold Gatty Drive Salt Lake City, UT 84116 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-25 |
| Decision Date | 2021-07-23 |