510(k) K233647
K233647 is an FDA 510(k) premarket notification submitted by Baylis Medical Company, Inc. for the device "VersaCross Connect Transseptal Dilator". The FDA issued a decision of Substantially Equivalent on December 14, 2023. The device falls under product code DRE (Dilator, Vessel, For Percutaneous Catheterization), a Class II device regulated under 21 CFR 870.1310. Baylis Medical Company, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 14, 2023
- Date Received
- November 14, 2023
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dilator, Vessel, For Percutaneous Catheterization
- Device Class
- Class II
- Regulation Number
- 870.1310
- Review Panel
- CV
- Submission Type