510(k) K222663
K222663 is an FDA 510(k) premarket notification submitted by Dongguan TT Medical, Inc. for the device "MultiStage Balloon Dilatation Catheter". The FDA issued a decision of Substantially Equivalent on March 9, 2023. The device falls under product code FGE (Stents, Drains And Dilators For The Biliary Ducts), a Class II device regulated under 21 CFR 876.5010. Dongguan TT Medical, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 9, 2023
- Date Received
- September 2, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stents, Drains And Dilators For The Biliary Ducts
- Device Class
- Class II
- Regulation Number
- 876.5010
- Review Panel
- GU
- Submission Type