FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
VASCUTEK VASCUSOFT PLUS VASCULAR GRAFT
K Number: K960706
·
Decision Apr 25, 1996
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
187
Applicant Total
22
Review Days
64
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
- VASCUTEK VASCUSOFT PLUS VASCULAR GRAFT
- K Number
- K960706
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3450
- Medical Specialty
- Cardiovascular
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Carbomedics, Inc.
- Date Received
- February 21, 1996
- Decision Date
- April 25, 1996
- Product Code
- DSY
- 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 |
|---|---|---|---|
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DSY), ordered by most recent decision date.
Fusion Bioline Vascular Graft
FDA 510(k)
FDA Class 2
·Cardiovascular
Spiral Laminar Flow Vascular Arteriovenous Graft (AV0645)
FDA 510(k)
FDA Class 2
·Cardiovascular
Gelweave Vascular Prostheses
FDA 510(k)
FDA Class 2
·Cardiovascular
Gelsoft Plus Vascular Prostheses
FDA 510(k)
FDA Class 2
·Cardiovascular
Advanta VXT Vascular Graft, Flixene Vascular Graft
FDA 510(k)
FDA Class 2
·Cardiovascular
GORE® PROPATEN® Vascular Graft
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Carbomedics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K970375 | ANNULOFLO SYSTEM | Jul 25, 1997 | Substantially Equivalent - Subject to Tracking Reg. |
| K964665 | VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION) | Feb 19, 1997 | Substantially Equivalent - Subject to Tracking Reg. |
| K962154 | CARBOMEDICS HANDLE | Aug 27, 1996 | Substantially Equivalent |
| K960923 | CARBOMEDICS MITRAL ROTATOR | Apr 29, 1996 | Substantially Equivalent |
| K960169 | CARBOMEDICS VALVE TESTER | Apr 15, 1996 | Substantially Equivalent |
| K955588 | VASCUTEK GRAFT SIZER SET | Mar 7, 1996 | Substantially Equivalent - Subject to Tracking Reg. |
| K952184 | CARBOMEDICS SUPRA-ANNULAR VALVE SIZER | Nov 29, 1995 | Substantially Equivalent |
| K951368 | CARBOMEDICS EXENDED MITRAL ROTATOR | Jun 20, 1995 | Substantially Equivalent |
| K942736 | CARBOMEDICS(R) PROSTHETIC HEART VALVE HOLDER HANDLE | Jul 6, 1994 | Substantially Equivalent |
| K934951 | VALVE SIZER | Dec 10, 1993 | Substantially Equivalent |