FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EXPANDING VASCULAR SHEATH
K Number: K070865
·
Decision Oct 23, 2007
Classifications
1
FEI Numbers
273
Registration Numbers
273
Same Product Code
701
Applicant Total
14
Review Days
208
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- EXPANDING VASCULAR SHEATH
- K Number
- K070865
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Applied Medical
- Date Received
- March 29, 2007
- Decision Date
- October 23, 2007
- Product Code
- DYB
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- Y
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
Other Clearances by Applied Medical
| K Number | Device Name | ||
|---|---|---|---|
| K202818 | Voyant Fine Fusion Device (EB230) | Dec 16, 2021 | Substantially Equivalent |
| K191866 | GelPOINT Mini Advanced Access Platform | Apr 29, 2020 | Substantially Equivalent |
| K122619 | EPIX IRRIGATION PUMP, EPIX SUCTION IRRIGATION TUBING SET | Oct 2, 2012 | Substantially Equivalent |
| K003443 | SUCTION IRRIGATOR | Feb 1, 2001 | Substantially Equivalent |
| K002915 | FLEXIBLE OCCLUSION SYSTEM | Jan 8, 2001 | Substantially Equivalent |
| K915826 | BIO-POLAR FORCEPS | Jun 2, 1992 | Substantially Equivalent |
| K911462 | SURGICAL TROCAR | Apr 22, 1991 | Substantially Equivalent |
| K844673 | APPLIED GAUZE SPONGE 4X4X16 PLY | Apr 1, 1985 | Substantially Equivalent |
| K844677 | APPLIED GAUZE SPONGE 2X2X12 | Apr 1, 1985 | Substantially Equivalent |
| K844674 | APPLIED GAUZE SPONGE 2X2X8 PLY | Apr 1, 1985 | Substantially Equivalent |