510(k) K210185
K210185 is an FDA 510(k) premarket notification submitted by Talon Surgical for the device "CardioCurve Steerable Sheath". The FDA issued a decision of Substantially Equivalent on Jul 23, 2021. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 23, 2021
- Date Received
- Jan 25, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Introducer, Catheter
- Device Class
- Class II
- Regulation Number
- 870.1340
- Review Panel
- CV
- Submission Type
- 510(k)