FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CORONARY VEIN GRAFT MARKER
K Number: K882314
·
Decision Aug 4, 1988
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
187
Applicant Total
2
Review Days
62
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
- CORONARY VEIN GRAFT MARKER
- K Number
- K882314
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3450
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Med-Edge, Inc.
- Date Received
- June 3, 1988
- Decision Date
- August 4, 1988
- 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 Med-Edge, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K971966 | CORONARY VEIN GRAFT TAG MARKER | Jan 26, 1998 | Substantially Equivalent |