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 |