510(k) K241740
K241740 is an FDA 510(k) premarket notification submitted by Summa Therapeutics for the device "Finesse Injectable PTA Balloon Dilatation Catheter". The FDA issued a decision of Substantially Equivalent on July 16, 2024. The device falls under product code LIT (Catheter, Angioplasty, Peripheral, Transluminal), a Class II device regulated under 21 CFR 870.1250. Summa Therapeutics has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 16, 2024
- Date Received
- June 17, 2024
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Angioplasty, Peripheral, Transluminal
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type