FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Genie MAX Large Bore Introducer Sheath
K Number: K253652
·
Decision Jan 22, 2026
Classifications
1
FEI Numbers
273
Registration Numbers
273
Same Product Code
701
Applicant Total
1
Review Days
63
Basic Information
- Device Name
- Genie MAX Large Bore Introducer Sheath
- K Number
- K253652
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cultiv8 1, LLC
- Date Received
- November 20, 2025
- Decision Date
- January 22, 2026
- Product Code
- DYB
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DYB | Introducer, Catheter | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DYB), ordered by most recent decision date.
FieldFlex Steerable Sheath
FDA 510(k)
FDA Class 2
·Cardiovascular
Echo Large Bore Introducer Sheath
FDA 510(k)
FDA Class 2
·Cardiovascular
Introducer Sheath Set
FDA 510(k)
FDA Class 2
·Cardiovascular
Edwards eSheath+ introducer set
FDA 510(k)
FDA Class 2
·Cardiovascular
Aventus Introducer Sheath
FDA 510(k)
FDA Class 2
·Cardiovascular
Protaryx Transseptal Puncture Device (PTX2-001)
FDA 510(k)
FDA Class 2
·Cardiovascular