510(k) K231227
K231227 is an FDA 510(k) premarket notification submitted by Baylis Medical Company, Inc. for the device "SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath". The FDA issued a decision of Substantially Equivalent on December 20, 2023. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Baylis Medical Company, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 20, 2023
- Date Received
- April 28, 2023
- 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