510(k) K223633
K223633 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "Rubicon Control Support Catheter (H749394323506A1)". The FDA issued a decision of Substantially Equivalent on August 8, 2023. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Boston Scientific Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 8, 2023
- Date Received
- December 5, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Percutaneous
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type