510(k) K262674
K262674 is an FDA 510(k) premarket notification submitted by Kossel Medtech (Suzhou) Co., Ltd. for the device "Giranel Guiding Sheath Set". The FDA issued a decision of Substantially Equivalent on Oct 15, 2026. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Kossel Medtech (Suzhou) Co., Ltd. has 6 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 15, 2026
- Date Received
- Jul 30, 2026
- 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
- 510(k)