510(k) K251838
K251838 is an FDA 510(k) premarket notification submitted by Cardiocycle Medical(Suzhou) Co., Ltd. for the device "Introducer Sheath Set". The FDA issued a decision of Substantially Equivalent on October 21, 2025. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Cardiocycle Medical(Suzhou) Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 21, 2025
- Date Received
- June 16, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Introducer, Catheter
- Device Class
- Class II
- Regulation Number
- 870.1340
- Review Panel
- CV
- Submission Type