FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO SHORT INTRODUCER SHEATH
K Number: K042399
·
Decision Dec 17, 2004
Classifications
1
FEI Numbers
268
Registration Numbers
268
Same Product Code
682
Applicant Total
3
Review Days
105
Basic Information
- Device Name
- MODIFICATION TO SHORT INTRODUCER SHEATH
- K Number
- K042399
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- REX MEDICAL LP
- Date Received
- September 3, 2004
- Decision Date
- December 17, 2004
- 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.
AuST Steerable Sheath
FDA 510(k)
FDA Class 2
·Cardiovascular
Prelude Wave Hydrophilic Sheath Introducer
FDA 510(k)
FDA Class 2
·Cardiovascular
PeriCross Epicardial Access Kit
FDA 510(k)
FDA Class 2
·Cardiovascular
Edwards eSheath Optima introducer set
FDA 510(k)
FDA Class 2
·Cardiovascular
iSLEEVE Introducer Set
FDA 510(k)
FDA Class 2
·Cardiovascular
ViaOne Epicardial Access System
FDA 510(k)
FDA Class 2
·Cardiovascular