510(k) K231629
K231629 is an FDA 510(k) premarket notification submitted by Eosolutions, Corp. for the device "091 Balloon Guide Catheter". The FDA issued a decision of Substantially Equivalent on October 31, 2023. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 31, 2023
- Date Received
- June 5, 2023
- Clearance Type
- Special
- 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