510(k) K241158
K241158 is an FDA 510(k) premarket notification submitted by Asahi Intecc Co., Ltd. for the device "ASAHI Veloute; ASAHI Veloute C3; ASAHI Tellus; ASAHI Tellus C3". The FDA issued a decision of Substantially Equivalent on June 25, 2024. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Asahi Intecc Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 25, 2024
- Date Received
- April 26, 2024
- 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