510(k) K231101
K231101 is an FDA 510(k) premarket notification submitted by Flume Catheter Company, Ltd. for the device "Flume Catheter". The FDA issued a decision of Substantially Equivalent on June 29, 2023. The device falls under product code EZL (Catheter, Retention Type, Balloon), a Class II device regulated under 21 CFR 876.5130. Flume Catheter Company, Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 29, 2023
- Date Received
- April 18, 2023
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Retention Type, Balloon
- Device Class
- Class II
- Regulation Number
- 876.5130
- Review Panel
- GU
- Submission Type