FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO PINNACLE ROII HIFLOW INTRODUCER SHEATH
K Number: K062446
·
Decision Oct 23, 2006
Classifications
1
FEI Numbers
268
Registration Numbers
268
Same Product Code
682
Applicant Total
143
Review Days
62
Basic Information
- Device Name
- MODIFICATION TO PINNACLE ROII HIFLOW INTRODUCER SHEATH
- K Number
- K062446
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- TERUMO MEDICAL CORP.
- Date Received
- August 22, 2006
- Decision Date
- October 23, 2006
- 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
Other Clearances by TERUMO MEDICAL CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K111606 | PINNACLE PRECISION ACCESS SYSTEM | Oct 3, 2011 | Substantially Equivalent |
| K111556 | GLIDECROSS SUPPORT CATHETER | Jul 29, 2011 | Substantially Equivalent |
| K110540 | TERUMO SUPPORT CATHETER | May 13, 2011 | Substantially Equivalent |
| K102008 | GLIDESHEATH | Jul 21, 2010 | Substantially Equivalent |
| K091329 | PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH | May 29, 2009 | Substantially Equivalent |
| K082997 | TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER | Apr 15, 2009 | Substantially Equivalent |
| K090040 | RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP) | Feb 6, 2009 | Substantially Equivalent |
| K082847 | PINNACLE ROII INTRODUCER SHEATH | Oct 29, 2008 | Substantially Equivalent |
| K082519 | FINECROSS MG CORONARY MICRO-GUIDE CATHETER | Sep 26, 2008 | Substantially Equivalent |
| K082736 | RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER | Sep 24, 2008 | Substantially Equivalent |