510(k) clearance
Giranel Guiding Sheath Set
- 510(k) number
- K262674
- Applicant
- Kossel Medtech (Suzhou) Co., Ltd.
- Decision date
- Oct 15, 2026
- Date received
- Jul 30, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- DYB
- Device type
- Introducer, Catheter
- Device class
- Class II
- Regulation
- 21 CFR 870.1340
- Advisory committee
- Cardiovascular
- Statement or summary
- Summary
- Third party
- N
- Location
- Suzhou New District, CN